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Codman®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
CODMAN® FDA UDI
Generic Name
Manual cranial rotary handpiece, single-use FDA UDI
Device Name
CODMAN® Cranial Drill Bit, 5.8mm FDA UDI
Model / Reference
826608 FDA UDI
Description
CODMAN® Cranial Drill Bit, 5.8mm FDA UDI

Identifiers

Catalog Number
82-6608 FDA UDI
Primary DI / UDI-DI
10381780520344 FDA UDI
510(k) Number
K914479 FDA UDI
FDA Product Code
GWM FDA UDI
GMDN Term
Manual cranial rotary handpiece, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1620 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Manual cranial rotary handpiece, single-use

Codman® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual cranial rotary handpiece, single-use.

Cleared under the same submission

K914479 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 6d233c56-87b1-40f7-8d14-df6b3c70b620 36 fields · synced Jun 9, 2026