MONOMAX VLT 1(4) 90CM HR76 USA (M)

MONOMAX VLT 1(4) 90CM HR76 USA (M)
Monomax - B9941124

A single-strand (monofilament), synthetic thread made from a non-bioabsorbable polyester (e.g., polybutester) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

• Size of Thread (USP - Others) : 1
• Thread Material : polyhydroxibutyrate
• Length: 90.00 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NWJ

Device Name: Suture, Recombinant Technology

Device Class: 2

Physical State: Polymer (solid)

Definition: Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Produced through recombinant DNA technology

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: General soft tissues in the body.

Regulation Number: 878.4494

Third Party Flag: N

Medical Specialty: SU

Device Id: 04046963989392

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: 04046963989385

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