FDA.reportPublic FDA data

N/A

Primary DI
00841036006655
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
01-0153
Catalog number
01-0153
Published
2017-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRTSTRIPPER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036006655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036006655008410360066558410360066550841036006655

GMDN Terms#

Term, Definition table
TermDefinition
Tendon stripperA hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445944728SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944735SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944742SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944759SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944766SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944773SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944780SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944797SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944827SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944834SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304495SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304501SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304518SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346211SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346235SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346242SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
00190776419929MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776419936MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776416454MillenniumAvalign Technologies, Inc.HRT2026-02-16
00190776416249MillenniumAvalign Technologies, Inc.HRT2026-02-12
00190776416195MillenniumAvalign Technologies, Inc.HRT2026-02-06
04262494463112N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494463129N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494462542N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462566N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462573N/ADoppkon GmbH & Co. KGHRT2025-12-01
04262494462559N/ADoppkon GmbH & Co. KGHRT2025-11-28
B7685410380Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
B7685410410Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
00816342024488STRIPPER, SURGICALPARCUS MEDICAL LLCHRT2025-09-16