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Coseal Surgical Sealant Extended Applicator

FDA UDI

Class III (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name
Coseal Surgical Sealant Extended Applicator FDA UDI
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Device Name
The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components. FDA UDI
Model / Reference
934034 FDA UDI
Description
The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components. FDA UDI

Identifiers

Catalog Number
934034 FDA UDI
Primary DI / UDI-DI
00085412083339 FDA UDI
FDA Product Code
NBE FDA UDI
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI

Classification

Device Class
Class III 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 — 22 Centimeter FDA UDI

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

Coseal Surgical Sealant Extended Applicator by Baxter Healthcare Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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 c7219c2b-9e8a-430f-829c-dd2c235b2227 37 fields · synced May 30, 2026