FDA.report

N/A

Primary DI
00841036007102
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
01-0258
Catalog number
01-0258
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
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841036007102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036007102008410360071028410360071020841036007102

GMDN Terms

TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
00810220800102Adler Instrument CompanyAdler, Inc.GEG2026-05-26
00190776417987MillenniumAvalign Technologies, Inc.GEG2026-03-23
00190776417536MillenniumAvalign Technologies, Inc.GEG2026-02-27
B382SD9141051070Surgical DirectSurgical Direct, Inc.GEG2026-02-17
00190776416577MillenniumAvalign Technologies, Inc.GEG2026-02-16
B382SD62432250Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD9141051050Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD23020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD23030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD671050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD6716050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051060Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051080Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9206611040Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921316170Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921381050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD92263910000Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9226411030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD922658020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD923862510Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD940111100Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD1467010200Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD481003700Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD48820100Surgical DirectSurgical Direct, Inc.GEG2026-02-06
G3831056WM853543SURJEXSURJEXGEG2026-01-31
00190776415501MillenniumAvalign Technologies, Inc.GEG2026-01-27
00810123209743Adler Instrument CompanyAdler, Inc.GEG2026-01-02
00841336106802Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
00841336106819Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
B382SD91010Surgical DirectSurgical Direct, Inc.GEG2025-12-02