FDA.reportPublic FDA data

X-Change

Primary DI
04546540167736
Brand
X-Change
Company
Howmedica Osteonics Corp.
Model
0942-8-040
Catalog number
0942-8-040
Device description
RIM 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

Product Codes#

Code, Name table
CodeName
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540167736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540167736045465401677364546540167736

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868475757Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868477171Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868477232Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868477256Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868478086Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868475375Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868475962Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868475979Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476044Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476068Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476310Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476860Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868477881Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476372Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476556Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476662Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476761Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868475399Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868475559Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868476990Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868477447Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
07613327511659INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
07613327511802INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
07613327511864INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
00887868475481Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868475511Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868475894Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868477669Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868477744Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868476235Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-03-12