← Back to catalogue

Osteon

FDA UDI

Class I (US FDA UDI)

by Conmed Corporation

Identity

Trade Name
OSTEON FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
OSTEON BUR - ROUND, 8 FLUTES, CARBIDE, 4 X 30 MM FDA UDI
Model / Reference
00505611900 FDA UDI
Description
OSTEON BUR - ROUND, 8 FLUTES, CARBIDE, 4 X 30 MM FDA UDI

Identifiers

Catalog Number
5056-119 FDA UDI
Primary DI / UDI-DI
10845854005613 FDA UDI
FDA Product Code
GFF FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Orthopaedic bur, single-use

Osteon by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Conmed Corporation

Sources (1)

  • FDA UDI 219b0e39-b787-4b81-9375-e4e0de90bbfb 36 fields · synced Jun 1, 2026