FDA.reportPublic FDA data

TAPERLOC EXACT INSTRUMENTATION

Primary DI
05019279440245
Brand
TAPERLOC EXACT INSTRUMENTATION
Company
Biomet Uk Ltd
Model
31-103215
Catalog number
31-103215
Published
2017-07-28
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
HTRRASP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019279440245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05019279440245050192794402455019279440245

GMDN Terms#

Term, Definition table
TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.c
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
219322575
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
00889024683808Oxford® Partial Knee System5122111155122111152026-04-09
00889024683815Oxford® Partial Knee System5122111505122111502026-04-09
00889024683181Oxford® Partial Knee System1122111001122111002026-04-03
00889024683198Oxford® Partial Knee System1122112001122112002026-04-03
00889024683204Oxford® Partial Knee System1122113001122113002026-04-03
00889024683211Oxford® Partial Knee System1122114001122114002026-04-03
00889024683228Oxford® Partial Knee System1122115001122115002026-04-03
00889024683235Oxford® Partial Knee System1122116001122116002026-04-03
00889024683242Oxford® Partial Knee System1122117001122117002026-04-03
00889024683259Oxford® Partial Knee System1122211001122211002026-04-03
00889024683266Oxford® Partial Knee System1122212001122212002026-04-03
00889024683273Oxford® Partial Knee System1122213001122213002026-04-03
00889024683280Oxford® Partial Knee System1122214001122214002026-04-03
00889024683297Oxford® Partial Knee System1122215001122215002026-04-03
00889024683303Oxford® Partial Knee System1122216001122216002026-04-03
00889024683310Oxford® Partial Knee System1122217001122217002026-04-03
00889024683327Oxford® Partial Knee System1123111001123111002026-04-03
00889024683334Oxford® Partial Knee System1123112001123112002026-04-03
00889024683341Oxford® Partial Knee System1123113001123113002026-04-03
00889024683358Oxford® Partial Knee System1123114001123114002026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08806395408948PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408955PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408962PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408979PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408986PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408993PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395409006PulsarGS Medical Co., Ltd.HTR2022-11-01
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