TRYPTIK Ti TRY-BX 10 04-N

GUDID 07640375232021

ANATOMIC SMOOTH TRIAL RACK

SpineArt SA

Instrument tray, reusable
Primary Device ID07640375232021
NIH Device Record Key2ce56f8d-f01c-4d71-9e8f-b97ff0eddf16
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRYPTIK Ti
Version Model NumberTRY-BX 10 04-N
Catalog NumberTRY-BX 10 04-N
Company DUNS483016148
Company NameSpineArt SA
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
GS107640375232021 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


[07640375232021]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-28
Device Publish Date2025-11-20

On-Brand Devices [TRYPTIK Ti]

07640375234827Implant Holder Shaft with Slap Hammer
07640375232021ANATOMIC SMOOTH TRIAL RACK
07640375232014LORDOTIC TRIAL RACK
07640332476499TRYPTIK TI-LIFE HL AND XL INSTRUMENT BOX
07640332471050TRYPTIK TI - EXTRA LARGE SMOOTH TRIAL RACK
07640332471043TRYPTIK TI - HYPERLORDOTIC SMOOTH TRIAL RACK

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.