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LinkBio Instrument

FDA UDI

Class I (US FDA UDI)

by LinkBio Corp.

Identity

Trade Name
LinkBio Instrument FDA UDI
Generic Name
Knee stem prosthesis trial FDA UDI
Device Name
Fusion Nail Femoral Trial Right FDA UDI
Model / Reference
87-1402 FDA UDI
Description
Fusion Nail Femoral Trial Right FDA UDI

Identifiers

Primary DI / UDI-DI
00810022403037 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee stem prosthesis trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Knee stem prosthesis trial

LinkBio Instrument by LinkBio Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee stem prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LinkBio Corp.

Sources (1)

  • FDA UDI ed66bc37-110f-4eb2-bbd2-6603da66276e 33 fields · synced May 31, 2026