Adapter Sleeve 1034-0000J

GUDID 04546540169457

Morse/C-Taper

Howmedica Osteonics Corp.

Femoral head/stem prosthesis adaptor
Primary Device ID04546540169457
NIH Device Record Key652e4b21-5fdf-4fb1-984c-6261badaf37c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdapter Sleeve
Version Model Number1034-0000J
Catalog Number1034-0000J
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540169457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Adapter Sleeve]

04546540608406Universal V40 Taper Adapter Sleeve
04546540608390Universal V40 Taper Adapter Sleeve
04546540608383Universal V40 Taper Adapter Sleeve
04546540608345Universal C-Taper Adapter Sleeve
04546540608338Universal C-Taper Adapter Sleeve
04546540608321Universal C-Taper Adapter Sleeve
04546540608314Universal C-Taper Adapter Sleeve
04546540169457Morse/C-Taper

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