5596-1R-R-USA 5596-1R-R-USA

GUDID 07290110640750

Sterilizer,steam

TUTTNAUER ISRAEL LTD.

Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer
Primary Device ID07290110640750
NIH Device Record Key745df43e-dc28-4e51-ba93-bb387ba82869
Commercial Distribution StatusIn Commercial Distribution
Brand Name5596-1R-R-USA
Version Model Number5596-1R Model
Catalog Number5596-1R-R-USA
Company DUNS600030209
Company NameTUTTNAUER ISRAEL LTD.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110640750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLESterilizer, Steam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-17
Device Publish Date2021-05-09

Devices Manufactured by TUTTNAUER ISRAEL LTD.

07290110640606 - TIVA2 TD2023-06-28 High level Disinfector
07290110640613 - TIVA2-H TD2023-06-28 High Level Disinfector
07290110640880 - TIVA10-1V-HS-MD2023-06-28 High Level Disinfector
07290110640897 - TIVA10-2V-HS-MD2023-06-28 High Level Disinfector
07290110642013 - TIVA8-MD2023-06-28 High Level Didinfector
05060474070003 - Model T-Classic2022-11-30 Sterilizer ,steam
07290110640644 - T-Edge 10 2022-01-10 Sterilizer,steam
07290110640651 - T-Edge 10 2022-01-10 Sterilizer,steam

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