MONOMAX VIOLET 1(4)120CM HRT48 LOP(M)
MONOMAX - B0041310
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
- 50.00
- 0.00
Device Sizes
- Thread Material : polyhydroxibutyrate
- Size of Thread (USP - Others) : 1
- Length: 120.0 Centimeter
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: 04046963827663
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: 04046963827656
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
