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Osseofix +

FDA UDI

Class I (US FDA UDI)

by Teknimed

Identity

Trade Name
OSSEOFIX + FDA UDI
Generic Name
Orthopaedic cement preparation/delivery kit FDA UDI
Model / Reference
PRECISION PACK FDA UDI

Identifiers

Catalog Number
21302 FDA UDI
Primary DI / UDI-DI
03760177047044 FDA UDI
FDA Product Code
OAR FDA UDI
JDZ FDA UDI
GMDN Term
Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4200 FDA UDI
888.4210 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Osseofix + by Teknimed — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teknimed

Sources (1)

  • FDA UDI e8535be7-e5bc-4598-9e1f-6c2a5637bb22 34 fields · synced Jun 8, 2026