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OsteoMed

FDA UDI

Class I (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name
OsteoMed FDA UDI
Generic Name
Cannulated surgical drill bit, single-use, non-sterile FDA UDI
Device Name
1.7mm Cannulated Drill, Long, Quick Release FDA UDI
Model / Reference
316-0514 FDA UDI
Description
1.7mm Cannulated Drill, Long, Quick Release FDA UDI

Identifiers

Catalog Number
316-0514 FDA UDI
Primary DI / UDI-DI
00842528126684 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Cannulated surgical drill bit, single-use, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.7 Millimeter FDA UDI

Category: Cannulated surgical drill bit, single-use, non-sterile

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

Similar devices

Also classified as Cannulated surgical drill bit, single-use, non-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 d9507b71-d296-4cf5-b756-ae9fe4da5fd5 37 fields · synced May 31, 2026