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Integra® Jarit®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
Integra® Jarit® FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Integra® Jarit® Sterilization Indicator Cards Steam of EO Gas, Packages of 250 FDA UDI
Model / Reference
775300 FDA UDI
Description
Integra® Jarit® Sterilization Indicator Cards Steam of EO Gas, Packages of 250 FDA UDI

Identifiers

Catalog Number
775-300 FDA UDI
Primary DI / UDI-DI
10381780177302 FDA UDI
510(k) Number
K890765 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

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

Category: Chemical/physical sterilization process indicator

Integra® Jarit® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Cleared under the same submission

K890765 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 3a7a8a8c-1a89-47a0-b987-efb58860aa9f 37 fields · synced Jun 9, 2026