FDA.reportPublic FDA data

X-Change

Primary DI
04546540167743
Brand
X-Change
Company
Howmedica Osteonics Corp.
Model
0942-8-050
Catalog number
0942-8-050
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
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540167743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540167743045465401677434546540167743

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
00193982648084ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648114ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648152ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648183ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648206ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648275ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648299ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648305ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648336ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648527ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648619ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648626ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648688ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648695ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648725ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648749ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648756ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648794ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648893ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648978ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649029ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649050ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649098ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649166ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649197ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649203ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649227ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
08033390301329DELTALIMACORPORATE SPAMBL2025-06-10
08033390301336DELTALIMACORPORATE SPAMBL2025-06-10
00822409016174Tri-plusOrtho Development CorporationMBL2023-11-22