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X-Repair

FDA UDI

Class II (US FDA UDI)

by Synthasome, Inc.

Identity

Trade Name
X-Repair FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Device Name
X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 25mm (WxL) FDA UDI
Model / Reference
Z009-25 FDA UDI
Description
X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 25mm (WxL) FDA UDI

Identifiers

Catalog Number
Z009-25 FDA UDI
Primary DI / UDI-DI
B05500925 FDA UDI
FDA Product Code
OWW FDA UDI
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

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 — 25 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

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

X-Repair by Synthasome, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthasome, Inc.

Sources (1)

  • FDA UDI 5e27e302-3968-4af7-b0d5-72b9c97a0e12 36 fields · synced May 30, 2026