MDM 626-00-58J

GUDID 04546540666062

Liner- Cementless

Howmedica Osteonics Corp.

Acetabular shell
Primary Device ID04546540666062
NIH Device Record Key7b7d8160-688e-47ae-a582-148cf2ed62c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMDM
Version Model Number626-00-58J
Catalog Number626-00-58J
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 Dimensions

Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter58 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540666062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

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 [MDM]

04546540666062Liner- Cementless
04546540666055Liner- Cementless
04546540666048Liner- Cementless
04546540666031Liner- Cementless
04546540666024Liner- Cementless
04546540666017Liner- Cementless
04546540666000Liner- Cementless
04546540665997Liner- Cementless
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