JULIET Ti TL SPE-US 01 33-N

GUDID 07640375235244

ANTI-ROTATING INSERTER

SpineArt SA

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID07640375235244
NIH Device Record Key9bf57ecc-e511-4d3e-a404-f46993b024a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameJULIET Ti TL
Version Model NumberSPE-US 01 33-N
Catalog NumberSPE-US 01 33-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
GS107640375235244 [Primary]

FDA Product Code

HWRDriver, Prosthesis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


[07640375235244]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-24
Device Publish Date2022-10-14

On-Brand Devices [JULIET Ti TL]

07640375235268ANTI-ROTATING INSERTER, TUBE
07640375235251ANTI-ROTATING INSERTER, LOCKING HANDLE
07640375235244ANTI-ROTATING INSERTER
07640375235206U-JOINT DRIVER
07640332471036BASE

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