VERASENSE Handle 03000-501

GUDID 00816818020372

ORTHOSENSOR INC

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID00816818020372
NIH Device Record Key3f74917f-70a2-4fd0-8a2e-c0f319e8b017
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERASENSE Handle
Version Model NumberVERASENSE Handle
Catalog Number03000-501
Company DUNS005788130
Company NameORTHOSENSOR INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100816818020372 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


[00816818020372]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-09
Device Publish Date2016-09-23

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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