UHR UH1-53-26

GUDID 07613327017199

Bipolar Component

Howmedica Osteonics Corp.

Femoral head bipolar component

Primary Device ID	07613327017199
NIH Device Record Key	b0750f73-88a3-4341-bb76-fb41bb9d7203
Commercial Distribution Status	In Commercial Distribution
Brand Name	UHR
Version Model Number	UH1-53-26
Catalog Number	UH1-53-26
Company DUNS	058311945
Company Name	Howmedica Osteonics Corp.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter
Outer Diameter	53 Millimeter
Lumen/Inner Diameter	26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327017199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173499
Premarket Notification: K800207

FDA Product Code

KWL	Prosthesis, hip, hemi-, femoral, metal

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

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07613327017519	Bipolar Component
07613327017502	Bipolar Component
07613327017496	Bipolar Component
07613327017489	Bipolar Component
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07613327017441	Bipolar Component
07613327017434	Bipolar Component
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07613327017410	Bipolar Component
07613327017403	Bipolar Component
07613327017397	Bipolar Component
07613327017380	Bipolar Component
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07613327017342	Bipolar Component
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07613327017311	Bipolar Component
07613327017304	Bipolar Component
07613327017298	Bipolar Component
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07613327017199	Bipolar Component
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07613327017113	Bipolar Component
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07613327017083	Bipolar Component
07613327017076	Bipolar Component
07613327017069	Bipolar Component
07613327017052	Bipolar Component
07613327017045	Bipolar Component
07613327017038	Bipolar Component
07613327017021	Bipolar Component