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OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name
OsteoMed FDA UDI
Generic Name
Craniofacial fixation plate kit, non-bioabsorbable FDA UDI
Device Name
2.0mm, 5 Hole Lozenge Curved Plate with Screws, Sterile FDA UDI
Model / Reference
210-3002-SP FDA UDI
Description
2.0mm, 5 Hole Lozenge Curved Plate with Screws, Sterile FDA UDI

Identifiers

Catalog Number
210-3002-SP FDA UDI
Primary DI / UDI-DI
00845694047432 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Craniofacial fixation plate kit, non-bioabsorbable 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Craniofacial fixation plate kit, non-bioabsorbable

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

Similar devices

Also classified as Craniofacial fixation plate kit, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteomed Corp.

Sources (1)

  • FDA UDI 1961ad97-c545-466f-ae97-f23a6872c9b5 35 fields · synced May 30, 2026