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Coseal Surgical Sealant

FDA UDI

Class III (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name
Coseal Surgical Sealant FDA UDI
Generic Name
Surgical internal adhesive/sealant, synthetic polymer FDA UDI
Device Name
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself FDA UDI
Model / Reference
934070 FDA UDI
Description
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself FDA UDI

Identifiers

Catalog Number
934070 FDA UDI
Primary DI / UDI-DI
05413765404610 FDA UDI
FDA Product Code
NBE FDA UDI
GMDN Term
Surgical internal adhesive/sealant, synthetic polymer 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

Yes

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
Total Volume — 2 Milliliter FDA UDI

Category: Surgical internal adhesive/sealant, synthetic polymer

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

Similar devices

Also classified as Surgical internal adhesive/sealant, synthetic polymer.

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 9474e74a-f52e-4d3b-a5fe-692064d50140 37 fields · synced May 30, 2026