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GORE DUALMESH Biomaterial

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1DLMC200

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE DUALMESH BIOMATERIAL 10.0cmX15.0cmX2.0mm EUDAMED
GORE DUALMESH Biomaterial FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
GORE® DUALMESH® Biomaterial EUDAMED
GORE DUALMESH BIOMATERIAL 10.0cmX15.0cmX2.0mm FDA UDI
Model / Reference
1DLMC200 EUDAMEDFDA UDI
Description
GORE DUALMESH BIOMATERIAL 10.0cmX15.0cmX2.0mm FDA UDI

Identifiers

Catalog Number
1DLMC200 FDA UDI
Primary DI / UDI-DI
00733132601035 EUDAMEDFDA UDI
Basic UDI-DI
B-00733132601035 EUDAMED
510(k) Number
K992189 FDA UDI
FDA Product Code
FTL FDA UDI
EMDN Code
P900203 PTFE SURGICAL MESHES EUDAMED
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Height — 2 Millimeter FDA UDI
Width — 10 Centimeter FDA UDI
Length — 15 Centimeter FDA UDI

Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

GORE DUALMESH Biomaterial by W. L. Gore & Associates, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.

Cleared under the same submission

K992189 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (2)

  • FDA UDI 4d6fe080-4b16-47de-af56-96db143c5e19 37 fields · synced Jul 9, 2026
  • EUDAMED 722bfcf5-7f35-461b-a144-430b1a792d75 61 fields · synced Jul 9, 2026