STEELEX STE SET 6 (8) 4X45CM HRS48
Steelex - G0617814
Device Description
A single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 45 Centimeter
- Thread Material : stainless steel
- Size of Thread (USP - Others) : 6
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GAQ
Device Name: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 878.4495
Third Party Flag: N
Medical Specialty: SU
Code: PTX
Device Name: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
Device Class: 2
Physical State: Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs.
Definition: This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Submission Type ID: 4
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation Number: 878.4495
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 04046964272639
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04038653911097
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 04038653911097
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 04045439057368
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A