FDA.report

BALANCE MICROPLASTY BROACH

Primary DI
00880304459403
Brand
BALANCE MICROPLASTY BROACH
Company
Biomet Orthopedics, LLC
Model
31-200268
Catalog number
31-200268
Published
2017-07-28
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
HTQBROACH

Product Code Classifications

CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304459403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304459403008803044594038803044594030880304459403

GMDN Terms

TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
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
true
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
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889797112307Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00889797112314Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00810111222679BroachTreace Medical Concepts, Inc.HTQ2025-08-06
00822409130962N/AOrtho Development CorporationHTQ2025-06-25
00822409130979N/AOrtho Development CorporationHTQ2025-06-25
00840314269751gSourceGSOURCE LLCHTQ2025-06-16
00840286841740Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841757Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841764Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841771Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841788Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841795Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841801Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841818Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841825Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841832Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841849Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841856Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841863Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841870Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841887Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841894Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286840491TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840507TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840514TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840521TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840538TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840545TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840552Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840569TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21