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Permacol

FDA UDI

Class II (US FDA UDI)

by Sofradim Production

Identity

Trade Name
Permacol FDA UDI
Generic Name
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Device Name
Surgical Implant FDA UDI
Model / Reference
P050104 FDA UDI
Description
Surgical Implant FDA UDI

Identifiers

Primary DI / UDI-DI
10884523000016 FDA UDI
510(k) Number
K013625 FDA UDI
K120605 FDA UDI
FDA Product Code
FTM FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
Not 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
Length — 1 Centimeter FDA UDI
Width — 4 Centimeter FDA UDI
Depth — 0.5 Millimeter FDA UDI

Permacol by Sofradim Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K013625 also covers:

K120605 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sofradim Production

Sources (1)

  • FDA UDI f23e83c4-d8e4-4998-9a62-2cbe1612f472 38 fields · synced Jun 1, 2026