UHR UH1-64-28

GUDID 07613327017434

Bipolar Component

Howmedica Osteonics Corp.

Femoral head bipolar component
Primary Device ID07613327017434
NIH Device Record Key70a0241a-9c15-4ce4-beb7-602ee00658f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameUHR
Version Model NumberUH1-64-28
Catalog NumberUH1-64-28
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 Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter
Lumen/Inner Diameter28 Millimeter
Outer Diameter64 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327017434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, hip, hemi-, femoral, metal

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 [UHR]

07613327017519Bipolar Component
07613327017502Bipolar Component
07613327017496Bipolar Component
07613327017489Bipolar Component
07613327017472Bipolar Component
07613327017465Bipolar Component
07613327017458Bipolar Component
07613327017441Bipolar Component
07613327017434Bipolar Component
07613327017427Bipolar Component
07613327017410Bipolar Component
07613327017403Bipolar Component
07613327017397Bipolar Component
07613327017380Bipolar Component
07613327017373Bipolar Component
07613327017366Bipolar Component
07613327017359Bipolar Component
07613327017342Bipolar Component
07613327017335Bipolar Component
07613327017328Bipolar Component
07613327017311Bipolar Component
07613327017304Bipolar Component
07613327017298Bipolar Component
07613327017281Bipolar Component
07613327017274Bipolar Component
07613327017267Bipolar Component
07613327017250Bipolar Component
07613327017243Bipolar Component
07613327017236Bipolar Component
07613327017229Bipolar Component
07613327017212Bipolar Component
07613327017205Bipolar Component
07613327017199Bipolar Component
07613327017182Bipolar Component
07613327017175Bipolar Component
07613327017168Bipolar Component
07613327017151Bipolar Component
07613327017144Bipolar Component
07613327017137Bipolar Component
07613327017120Bipolar Component
07613327017113Bipolar Component
07613327017106Bipolar Component
07613327017090Bipolar Component
07613327017083Bipolar Component
07613327017076Bipolar Component
07613327017069Bipolar Component
07613327017052Bipolar Component
07613327017045Bipolar Component
07613327017038Bipolar Component
07613327017021Bipolar Component
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.