FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327256239
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
5555-2255
Catalog number
5555-2255
Device description
TRIATHLON SINGLE-USE FEMORAL PREP KIT
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327256239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327256239076133272562397613327256239

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327670936TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670950TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670974TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670981TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671032TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671049TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671056TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671094TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671100TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671131TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671148TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671186TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671209TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671216TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671230TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671247TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671254TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671261TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671278TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671285TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671315TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671322TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671346TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671377TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671384TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671407TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671421TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671445TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671469TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671483TriathlonHowmedica Osteonics Corp.MBH2026-02-26