FDA.reportPublic FDA data

N/A

Primary DI
00841036024208
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
03-1145
Catalog number
03-1145
Published
2018-08-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXGTAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036024208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036024208008410360242088410360242080841036024208

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. 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
00190776416423MillenniumAvalign Technologies, Inc.HXG2026-02-16
00190776416430MillenniumAvalign Technologies, Inc.HXG2026-02-16
00190376538990Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HXG2026-02-10
00190376694351IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00190376694368Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HXG2026-02-10
00190376700700IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00190376700717IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00810112598902TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXG2026-02-10
00190776415723MillenniumAvalign Technologies, Inc.HXG2026-02-04
04026575341153Endo-Model Knee Fusion Nail SK InstrumentsWALDEMAR LINK GmbH & Co. KGHXG2026-02-02
00840180543429General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
00840180543597General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
00840180543757General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
03662663155625Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-29
03662663156707Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-29
10889981285999FacetSeaspine Orthopedics CorporationHXG2025-12-19
03662663242233Alta ACDF SystemHighridge Medical, LLCHXG2025-12-18
03662663242240Alta ACDF SystemHighridge Medical, LLCHXG2025-12-18
03662663160674Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-16
03662663160681Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-16
03662663160698Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-16
03662663246620Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
03662663254113Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
03662663254120Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
00190376662176IdentiTi IIALPHATEC SPINE, INC.HXG2025-12-08
00199150041930Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2025-11-20
03662663070942TMT InstrumentsHighridge Medical, LLCHXG2025-11-16
03662663071581TMT InstrumentsHighridge Medical, LLCHXG2025-11-16
00888480363101C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHXG2025-11-14
00888480637370Breckenridge ACDF SystemHighridge Medical, LLCHXG2025-11-14