Skin Stapler STERILE
McKesson - 16-3001
Device Description
A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GAG
Device Name: Stapler, Surgical
Device Class: 2
Physical State: A specialized prescription device that delivers compatible staples to internal tissues.
Definition: A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A specialized prescription device that delivers compatible staples to internal tissues.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Internal tissues.
Regulation Number: 878.4740
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 20612479214785
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10612479214801
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 10612479214801
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: 40612479214796
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20612479214785
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case