FDA.reportPublic FDA data

NA

Primary DI
00889024458963
Brand
NA
Company
Zimmer, Inc.
Model
32-5014-56
Published
2016-09-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024458963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024458963008890244589638890244589630889024458963

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.FTM2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.FTM2026-03-24
09421908222409Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222423Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222447Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
00850047730305Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850038226008InvengenxTisgenx, Inc.FTM2025-05-28
00850038226015InvengenxTisgenx, Inc.FTM2025-05-28
00850038226022InvengenxTisgenx, Inc.FTM2025-05-28
00850038226039InvengenxTisgenx, Inc.FTM2025-05-28
00850038226046InvengenxTisgenx, Inc.FTM2025-05-28
00850038226053InvengenxTisgenx, Inc.FTM2025-05-28
00850038226060InvengenxTisgenx, Inc.FTM2025-05-28
00850038226077InvengenxTisgenx, Inc.FTM2025-05-28
00850038226084InvengenxTisgenx, Inc.FTM2025-05-28
00850038226091InvengenxTisgenx, Inc.FTM2025-05-28