- Physicians Office Resource

MONOMAX VIOLET 2/0 (3) 70CM FR26 (M)
MONOMAX - B0041887

Device Description

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

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

50.00
0.00

Device Sizes

Length: 70.0 Centimeter

Thread Material : polyhydroxibutyrate

Size of Thread (USP - Others) : 2/0

Length: 70.0 Centimeter
Thread Material : polyhydroxibutyrate
Size of Thread (USP - Others) : 2/0

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 04046964098680

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: 04046964098673

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

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