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Tisseel/Artiss Spray Set

FDA UDI

Class II (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name
TISSEEL/ARTISS SPRAY SET FDA UDI
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Device Name
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and a clip to be attached to the double syringe system plunger for gas activation. FDA UDI
Model / Reference
1504266 FDA UDI
Description
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and a clip to be attached to the double syringe system plunger for gas activation. FDA UDI

Identifiers

Catalog Number
1504266 FDA UDI
Primary DI / UDI-DI
05413765583438 FDA UDI
510(k) Number
K050495 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

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

Tisseel/Artiss Spray Set by Baxter Healthcare 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

K050495 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA UDI efd3eadf-2f00-4e77-9a10-db68e7968b77 37 fields · synced May 30, 2026