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CoLink LapiFix

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name
CoLink LapiFix FDA UDI
Generic Name
Staple line-reinforcement strip FDA UDI
Device Name
CoLink LapiFix ASSEMBLY RIGHT FDA UDI
Model / Reference
C01 N4011 FDA UDI
Description
CoLink LapiFix ASSEMBLY RIGHT FDA UDI

Identifiers

Catalog Number
C01 N4011 FDA UDI
Primary DI / UDI-DI
00810021866529 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Staple line-reinforcement strip FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Staple line-reinforcement strip

CoLink LapiFix by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Staple line-reinforcement strip.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2Bones, USA

Sources (1)

  • FDA UDI cb03e041-6daf-43bc-8681-c7e6c70bc575 35 fields · synced Jun 8, 2026