Twinfix

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: TWINFIX FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: TWINFIX 2.8 MM TITANIUM SINGLE ANCHOR, STERILE FDA UDI
Model / Reference: 7209107 FDA UDI
Description: TWINFIX 2.8 MM TITANIUM SINGLE ANCHOR, STERILE FDA UDI

Identifiers

Catalog Number: 7209107 FDA UDI
Primary DI / UDI-DI: 03596010448422 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Suturing unit, single-use

Twinfix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI d8bc89a5-0689-4711-9021-15dae9ee418d 35 fields · synced Jun 8, 2026