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Integra®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra® FDA UDI
Generic Name
Neurosurgical retraction system, brain FDA UDI
Device Name
Integra® Tew 4mm x 7-1/2" Micro FDA UDI
Model / Reference
438A1083D FDA UDI
Description
Integra® Tew 4mm x 7-1/2" Micro FDA UDI

Identifiers

Catalog Number
438A1083D FDA UDI
Primary DI / UDI-DI
10381780253105 FDA UDI
510(k) Number
K830332 FDA UDI
FDA Product Code
GZT FDA UDI
GMDN Term
Neurosurgical retraction system, brain FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Neurosurgical retraction system, brain

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

Similar devices

Also classified as Neurosurgical retraction system, brain.

Cleared under the same submission

K830332 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI 5970f6c2-96ed-4c63-b06e-5fd1e295704f 37 fields · synced May 30, 2026