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Integra®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra® FDA UDI
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Device Name
Integra® Single Use Extended Tip Applicator 15cm FDA UDI
Model / Reference
205115 FDA UDI
Description
Integra® Single Use Extended Tip Applicator 15cm FDA UDI

Identifiers

Catalog Number
20-5115 FDA UDI
Primary DI / UDI-DI
10381780540588 FDA UDI
510(k) Number
K091315 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 15 Centimeter FDA UDI

Category: Open-surgery adhesive/sealant applicator, dual-channel

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

Similar devices

Also classified as Open-surgery adhesive/sealant applicator, dual-channel.

Cleared under the same submission

K091315 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 e8fe3bae-23ef-483a-a778-067bc4628487 38 fields · synced May 30, 2026