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Flexband Fix

FDA UDI

Class II (US FDA UDI)

by Artelon

Identity

Trade Name
FLEXBAND FIX FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Device Name
FLEXBAND Fix Kit 5 Pack FDA UDI
Model / Reference
51013 FDA UDI
Description
FLEXBAND Fix Kit 5 Pack FDA UDI

Identifiers

Catalog Number
51013 FDA UDI
Primary DI / UDI-DI
00850003396217 FDA UDI
FDA Product Code
QWJ FDA UDI
MBI FDA UDI
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbableExtra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Flexband Fix by Artelon — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Artelon

Sources (1)

  • FDA UDI 9da1b3f9-ce77-4ad8-95a5-f5b9fd3c8824 35 fields · synced May 30, 2026