AccessGUDID - DEVICE: X-Change (04546540167712)

GUDID

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Device Identifier (DI) Information

Brand Name: X-Change
Version or Model: 0942-8-025
Catalog Number: 0942-8-025
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 04546540167712
Issuing Agency: GS1
Device Count: 1

Device Description: WALL MESH

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multi-purpose surgical mesh, metallic	A sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

GMDN Preferred Term Name

GMDN Definition

Multi-purpose surgical mesh, metallic

A sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

FDA Product Code

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Product Code	Product Code Name
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
JDJ	Mesh, surgical, acetabular, hip, prosthesis
KWL	Prosthesis, hip, hemi-, femoral, metal
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: SM

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2015
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: X-Change (04546540167712)