ProSup

FDA UDI

Class II (US FDA UDI)

by Sofradim Production

Identity

Trade Name: ProSup FDA UDI
Generic Name: Pelvic organ prolapse surgical mesh, synthetic polymer FDA UDI
Device Name: Pelvic Floor Repair Mesh,Polyester FDA UDI
Model / Reference: TECG3004 FDA UDI
Description: Pelvic Floor Repair Mesh,Polyester FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521177574 FDA UDI
510(k) Number: K982532 FDA UDI
FDA Product Code: FTL FDA UDI
GMDN Term: Pelvic organ prolapse surgical mesh, synthetic polymer 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

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

FDA UDI

Dimensions & Sizes

Size: Height — 4 Centimeter FDA UDI
Width — 30 Centimeter FDA UDI

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

Cleared under the same submission

K982532 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 II	Pending data

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Manufacturer

Manufacturer: Sofradim Production

Sources (1)

FDA UDI 7581ae25-fbf8-4adb-adfb-ea9be47d5332 37 fields · synced May 29, 2026