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Integra®

FDA UDI

Class II (US 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® Single Sterile Drill Bit with Collar 13/64" (5.31 mm) FDA UDI
Model / Reference
SP0087 FDA UDI
Description
Integra® Single Sterile Drill Bit with Collar 13/64" (5.31 mm) FDA UDI

Identifiers

Catalog Number
SP0087 FDA UDI
Primary DI / UDI-DI
10381780537335 FDA UDI
510(k) Number
K961113 FDA UDI
FDA Product Code
HBG FDA UDI
GMDN Term
Manual cranial rotary handpiece, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4300 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

Yes

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

Category: Manual cranial rotary handpiece, single-use

Integra® by Integra Pain Management — 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

K961113 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Pain Management

Sources (1)

  • FDA UDI 68bfff6e-580f-42e2-91e8-21713c29d673 37 fields · synced Jun 9, 2026