VERASENSE for Stryker Triathlon SYK-TRCR05

GUDID 00816818021560

ORTHOSENSOR INC

Arthroplasty force sensor
Primary Device ID00816818021560
NIH Device Record Keyb0c30764-fea3-4347-a1c8-687e30545749
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERASENSE for Stryker Triathlon
Version Model NumberVERASENSE for Stryker Triathlon CR Size 5
Catalog NumberSYK-TRCR05
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 Usetrue
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

Customer Support Contacts

Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com
Phone954-577-7770
Emailcustomerservice@orthosensor.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816818021560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONNIntraoperative Orthopedic Joint Assessment Aid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2020-11-18

On-Brand Devices [VERASENSE for Stryker Triathlon]

00816818021584VERASENSE for Stryker Triathlon CR Size 7
00816818021577VERASENSE for Stryker Triathlon CR Size 6
00816818021560VERASENSE for Stryker Triathlon CR Size 5
00816818021553VERASENSE for Stryker Triathlon CR Size 4
00816818021546VERASENSE for Stryker Triathlon CR Size 3
00816818021539VERASENSE for Stryker Triathlon CR Size 2

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