FDA.report

N/A

Primary DI
00841036008482
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
01-0630
Catalog number
01-0630
Published
2017-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841036008482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036008482008410360084828410360084820841036008482

GMDN Terms

TermDefinition
Orthopaedic retractorA hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags

DUNS number
046189866
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00888233016902N/ASP-2482SP-24822020-06-16
008882330182272.0MM SYSTEMSP-2640SP-26402020-06-16
00888233078986VENAPAX XLVPX40002025-03-31
00888233012430N/ASP-1634SP-16342020-06-16
00888233013680CMF SYSTEMSP-1883SP-18832020-06-16
00888233013703CMF SYSTEMSP-1884SP-18842020-06-16
00888233013727CMF SYSTEMSP-1885SP-18852020-06-16
00888233013741CMF SYSTEMSP-1886SP-18862020-06-16
00888233025348LactoSorb SystemSP-1688SP-16882020-06-16
00888233025355LactoSorb SystemSP-1689SP-16892020-06-16
00888233025362LactoSorb SystemSP-1690SP-16902020-06-16
00888233025379LactoSorb System - MandibularSP-1778SP-17782020-06-16
00888233025386LactoSorb System - MandibularSP-1779SP-17792020-06-16
00888233025645LactoSorb System - MandibularSP-1944SP-19442020-06-16
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23
00198506089695ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-20
00199150062263Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062270Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062287Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00840277133427Innomed, Inc.INNOMED, INC.GAD2026-03-20
00198506055393ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-19
10885862648587EquinoxeExactech, Inc.GAD2026-03-19
10885862648594EquinoxeExactech, Inc.GAD2026-03-19
10885862661234N/AExactech, Inc.GAD2026-03-19
10885862661371NovationExactech, Inc.GAD2026-03-19
10885862661388NovationExactech, Inc.GAD2026-03-19
10885862661395NovationExactech, Inc.GAD2026-03-19
10885862661401NovationExactech, Inc.GAD2026-03-19
00198506089671ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00198506089688ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00810123209996Adler Instrument CompanyAdler, Inc.GAD2026-03-17
00810220800027Adler Instrument CompanyAdler, Inc.GAD2026-03-17
20763000284897OctoBase™MEDTRONIC, INC.GAD2026-03-14
00841536147766ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147773ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147780ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00810158219298PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
00810158219342PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
M93074301120S0Life InstrumentsLife Instrument CorporationGAD2026-03-12