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OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name
OsteoMed FDA UDI
Generic Name
Orthopaedic bone washer, sterile FDA UDI
Device Name
Drill Sleeve, 6.5/7.0 Cannulated Screws FDA UDI
Model / Reference
316-1722 FDA UDI
Description
Drill Sleeve, 6.5/7.0 Cannulated Screws FDA UDI

Identifiers

Catalog Number
316-1722 FDA UDI
Primary DI / UDI-DI
00842528104132 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone washer, sterile 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone washer, sterile

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

Similar devices

Also classified as Orthopaedic bone washer, 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 d8966072-69b7-4a01-a354-d7e551770bd3 36 fields · synced May 30, 2026