ROSA Cup Inserter Handle 20-8060-301-00

GUDID 00887868518522

Orthosoft Inc

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Primary Device ID00887868518522
NIH Device Record Keyc3e62604-1636-48c0-aa46-e1df734082ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameROSA Cup Inserter Handle
Version Model Number20-8060-301-00
Catalog Number20-8060-301-00
Company DUNS205670032
Company NameOrthosoft 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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868518522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-01
Device Publish Date2021-08-24

Devices Manufactured by Orthosoft Inc

00887868557873 - ROSA® Shoulder2024-03-14
00887868557880 - ROSA® Shoulder2024-03-14
00887868557897 - ROSA® Shoulder2024-03-14
00887868557903 - ROSA® Shoulder2024-03-14
00887868557910 - ROSA® Shoulder2024-03-14
00887868558078 - ROSA® Shoulder2024-03-14
00887868558092 - ROSA® Shoulder2024-03-14
00887868558108 - ROSA® Shoulder2024-03-14

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