T-Edge 10 AMS10-230-T

GUDID 07290110640439

Sterilizer, steam

TUTTNAUER ISRAEL LTD.

Steam sterilizer
Primary Device ID07290110640439
NIH Device Record Keyf55431b5-0ac5-4e0a-b332-a4222119d791
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Edge 10
Version Model NumberT-Edge 10
Catalog NumberAMS10-230-T
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
GS107290110640439 [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 Date2019-12-05
Device Publish Date2019-11-27

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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