- Physicians Office Resource

Monofilament Polypropylene
Surgipro II - XX-2101

Device Description

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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 heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

130.00
N/A

Device Sizes

Diameter,6/0,N/A;

Length: 24 Inch

Diameter,6/0,N/A;
Length: 24 Inch

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GAW

Device Name: Suture, Nonabsorbable, Synthetic, Polypropylene

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: 878.5010

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 20884521196305

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521196308

Package Quantity: 12

Package Discontinue Date: 9/2/2015 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE

Device Id: 10884521196308

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

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