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Integra®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra® FDA UDI
Generic Name
Device sterilization/disinfection container, reusable FDA UDI
Device Name
Integra® Sterilization Case for UCHR-A FDA UDI
Model / Reference
UCHRCASE FDA UDI
Description
Integra® Sterilization Case for UCHR-A FDA UDI

Identifiers

Catalog Number
UCHRcase FDA UDI
Primary DI / UDI-DI
10381780252399 FDA UDI
510(k) Number
K160811 FDA UDI
K944463 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Device sterilization/disinfection container, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

Cleared under the same submission

K160811 also covers:

K944463 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 7a275ea7-7ffa-4af8-a43f-5f9085d64465 37 fields · synced May 31, 2026