VERASENSE Software Application 05000-VRSE

GUDID 07613327581843

ORTHOSENSOR INC

Arthroplasty force sensor display unit
Primary Device ID07613327581843
NIH Device Record Keyd53cada9-ef12-4061-a4cc-6d4c3040726c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERASENSE Software Application
Version Model Number5.6.1.138
Catalog Number05000-VRSE
Company DUNS005788130
Company NameORTHOSENSOR 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 Batchfalse
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 Identifiers

Device Issuing AgencyDevice ID
GS107613327581843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONNIntraoperative Orthopedic Joint Assessment Aid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-01
Device Publish Date2022-08-24

Devices Manufactured by ORTHOSENSOR INC

00816818021478 - VERASENSE for Zimmer Biomet Persona2023-05-03
00816818021485 - VERASENSE for Zimmer Biomet Persona2023-05-03
00816818021492 - VERASENSE for Zimmer Biomet Persona2023-05-03
00816818021508 - VERASENSE for Zimmer Biomet Persona2023-05-03
00816818021515 - VERASENSE for Zimmer Biomet Persona2023-05-03
00816818021522 - VERASENSE for Zimmer Biomet Persona2023-05-03
00816818021539 - VERASENSE for Stryker Triathlon2023-05-03
00816818021546 - VERASENSE for Stryker Triathlon2023-05-03

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