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OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name
OsteoMed FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
ExtremiFix Large, Large Screw System Tray Base FDA UDI
Model / Reference
316-1902 FDA UDI
Description
ExtremiFix Large, Large Screw System Tray Base FDA UDI

Identifiers

Catalog Number
316-1902 FDA UDI
Primary DI / UDI-DI
00842528104026 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Instrument tray, reusable 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

OsteoMed by Osteomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument tray, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteomed Corp.

Sources (1)

  • FDA UDI e7f9dfb5-956d-4183-8b21-89f2dc128a1f 36 fields · synced May 31, 2026