DuraSeal®

FDA UDI

Class III (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: DuraSeal® FDA UDI
Generic Name: Dura mater sealant FDA UDI
Device Name: DuraSeal® Dural Sealant System Polymer Kit 5 mL FDA UDI
Model / Reference: 202050 FDA UDI
Description: DuraSeal® Dural Sealant System Polymer Kit 5 mL FDA UDI

Identifiers

Catalog Number: 202050 FDA UDI
Primary DI / UDI-DI: 10381780537175 FDA UDI
PMA Number: P040034 FDA UDI
FDA Product Code: NQR FDA UDI
GMDN Term: Dura mater sealant 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 5 Milliliter FDA UDI

Category: Dura mater sealant

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

Similar devices

Also classified as Dura mater sealant.

SpineSeal Spine Sealant — Pramand, LLC · Class III
CraniSeal Dural Sealant — Pramand, LLC · Class III
Adherus AutoSpray Dural Sealant — HYPERBRANCH MEDICAL TECHNOLOGY INC · Class III
Better Touch — CENTRAL ASSOCIATION FOR THE BLIND, INC. · Class I
Adherus AutoSpray ET Dural Sealant — HYPERBRANCH MEDICAL TECHNOLOGY INC · Class III
DuraSeal® — Integra Lifesciences Corp. · Class III
DuraSeal® — Integra Lifesciences Corp. · Class III
DuraSeal Exact Spinal Sealant System — Integra Lifesciences Corp. · Class III

Cleared under the same submission

P040034 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI a7992cdb-3b6c-4321-a5a3-0df58ab2a53b 38 fields · synced May 31, 2026