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: 202010DS FDA UDI
Description: DuraSeal® Dural Sealant System Polymer Kit 5 mL FDA UDI

Identifiers

Catalog Number: 202010DS FDA UDI
Primary DI / UDI-DI: 10381780542179 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 Exact Spinal Sealant System — Integra Lifesciences Corp. · Class III
DuraSeal® — 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

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 7d40b5d9-c0cb-4164-876b-8c4cdf6c8d46 38 fields · synced Jun 6, 2026