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OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name
OsteoMed FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
Device Name
NeuroPack, Profile 0, 1 Large Bur Hole plate, 6 AutoDrive screws FDA UDI
Model / Reference
218-0079-SP FDA UDI
Description
NeuroPack, Profile 0, 1 Large Bur Hole plate, 6 AutoDrive screws FDA UDI

Identifiers

Catalog Number
218-0079-SP FDA UDI
Primary DI / UDI-DI
00845694053563 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

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

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteomed Corp.

Sources (1)

  • FDA UDI 98750782-918c-4048-b04a-052c43b51d02 35 fields · synced Jun 1, 2026