Integra®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Integra® FDA UDI
Generic Name: Stereotactic radiosurgical invasive head frame FDA UDI
Device Name: Integra® Drill Assembly, 4.6mm w/GT FDA UDI
Model / Reference: DA46 FDA UDI
Description: Integra® Drill Assembly, 4.6mm w/GT FDA UDI

Identifiers

Catalog Number: DA46 FDA UDI
Primary DI / UDI-DI: 10381780251576 FDA UDI
510(k) Number: K944463 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Stereotactic radiosurgical invasive head frame FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Stereotactic radiosurgical invasive head frame

Integra® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic radiosurgical invasive head frame.

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Headpins — Brainlab SE · Class II
Headpins — Brainlab SE · Class II
Cranial Screw - Short — Varian Medical Systems, Inc · Class II
Cranial Screw - Short/Long — Varian Medical Systems, Inc · Class II
Headpins — Brainlab SE · Class II

Cleared under the same submission

K944463 also covers:

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	Class II	Pending data

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 759167a8-a5b6-4434-bc9d-06da0b5a98dc 36 fields · synced May 31, 2026