FDA.reportPublic FDA data

N/A

Primary DI
00841036084394
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
03-0188
Catalog number
03-0188
Published
2018-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036084394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036084394008410360843948410360843940841036084394

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536017546tezoUlrich GmbH & Co. KGFZO2026-03-12
00190776417598MillenniumAvalign Technologies, Inc.FZO2026-03-04
00190776417604MillenniumAvalign Technologies, Inc.FZO2026-03-04
03662663109215Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
03662663109222Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
04058749067538NAFehling Instruments GmbH & Co. KGFZO2026-01-28
04058749075991NAFehling Instruments GmbH & Co. KGFZO2026-01-28
00190776415280MillenniumAvalign Technologies, Inc.FZO2026-01-27
00889024703872Offset Box OsteotomeZimmer, Inc.FZO2025-12-18
03662663271349Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271356Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271363Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271370Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271394Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271400Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271417Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271431Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271455Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271462Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271479Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271493Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271509Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271516Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271523Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271530Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271547Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271554Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271561Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271578Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271585Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18