Integra®

FDA UDI

by Integra Pain Management

Identity

Trade Name: Integra® FDA UDI
Generic Name: Manual cranial rotary handpiece, single-use FDA UDI
Device Name: Integra® Cranial Drill Procedure Kit FDA UDI
Model / Reference: SP0158 FDA UDI
Description: Integra® Cranial Drill Procedure Kit FDA UDI

Identifiers

Catalog Number: SP0158 FDA UDI
Primary DI / UDI-DI: 10381780264835 FDA UDI
GMDN Term: Manual cranial rotary handpiece, single-use FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Manual cranial rotary handpiece, single-use

Integra® by Integra Pain Management — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

CODMAN® — Integra LifeSciences Production Corporation · Class II
CODMAN® — Integra LifeSciences Production Corporation · Class II
CODMAN® — Integra LifeSciences Production Corporation · Class II
CODMAN® — Integra LifeSciences Production Corporation · Class II
Integra® — Integra Pain Management · Class II
Integra® — Integra Pain Management
Integra® — Integra Pain Management
Integra® — Integra Pain Management · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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

Manufacturer

Manufacturer: Integra Pain Management

Sources (1)

FDA UDI c6b38b99-76d8-4cfc-b4de-f1d9d109195c 36 fields · synced Jun 9, 2026