160mm Oval Ring

GUDID 00810028396722

Medshape, Inc.

External orthopaedic fixation system, reusable
Primary Device ID00810028396722
NIH Device Record Key82d08e10-0183-497b-86d6-b9636810d311
Commercial Distribution StatusIn Commercial Distribution
Brand Name160mm Oval Ring
Version Model NumberDNE-160-OV
Company DUNS601306413
Company NameMedshape, Inc.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028396722 [Primary]

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


[00810028396722]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-07-09
Device Publish Date2024-05-31

On-Brand Devices [160mm Oval Ring]

00810028396593DNE-160-OV
00810028396722DNE-160-OV

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.