← Back to catalogue

X-Change

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
X-Change FDA UDI
Generic Name
Extra-gynaecological surgical mesh, metal FDA UDI
Device Name
FEMORAL MESH FDA UDI
Model / Reference
0942-8-010 FDA UDI
Description
FEMORAL MESH FDA UDI

Identifiers

Catalog Number
0942-8-010 FDA UDI
Primary DI / UDI-DI
04546540167699 FDA UDI
FDA Product Code
LZO FDA UDI
LPH FDA UDI
LWJ FDA UDI
JDI FDA UDI
JDJ FDA UDI
KWL FDA UDI
MEH FDA UDI
KWY FDA UDI
KWZ FDA UDI
MBL FDA UDI
MAY FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, metal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3358 FDA UDI
888.3360 FDA UDI
888.3350 FDA UDI
878.3300 FDA UDI
888.3390 FDA UDI
888.3310 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Extra-gynaecological surgical mesh, metal

X-Change by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, metal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Howmedica Osteonics Corp.

Sources (1)

  • FDA UDI d2125b05-3274-45c5-bd1f-81d66898a569 34 fields · synced Jun 1, 2026