FDA.report

X-Change

Primary DI
04546540167705
Brand
X-Change
Company
Howmedica Osteonics Corp.
Model
0942-8-020
Catalog number
0942-8-020
Device description
WALL MESH
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546540167705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540167705045465401677054546540167705

GMDN Terms

TermDefinition
Multi-purpose surgical mesh, metallicA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
058311945
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00887868575563Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
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