FDA.reportPublic FDA data

T-Edge 10

Primary DI
07290110640439
Brand
T-Edge 10
Company
TUTTNAUER ISRAEL LTD.
Model
T-Edge 10
Catalog number
AMS10-230-T
Device description
Sterilizer, steam
Published
2019-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143311000
K213080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143311000Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd.2015-01-15FLE
K213080000T-Edge 10, T-Edge 11Tuttnauer , Ltd.2022-01-04FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110640439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110640439072901106404397290110640439

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600030209
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110640606TIVA2 TDTIVA2 TDTIVA2 TD2023-06-20
07290110640613TIVA2-H TDTIVA2-H TDTIVA2-H TD2023-06-20
07290110640880TIVA10-1V-HS-MDTIVA10-1V-HS-MDTIVA10-1V-HS-MD2023-06-20
07290110640897TIVA10-2V-HS-MDTIVA10-2V-HS-MDTIVA10-2V-HS-MD2023-06-20
07290110642013TIVA8-MDTIVA8-MDTIVA8-MD2023-06-20
072901106407983870HSG3870HSG-WS-230-D2022-12-22
072901106422353870HSG3870HSG-230-D2022-12-22
05060474070003Model T-ClassicModel T-Classic2022-11-22
07290110640644T-Edge 10 T-Edge 10 AMS10-120-W-T2020-11-16
07290110640651T-Edge 10 T-Edge 10 AMS10-120-T 2020-11-16
07290110640729T-Edge 11 AMS11-230-W-T AMS11-230-W-T2021-06-07
07290110640736T-Edge 11 AMS11-230-T AMS11-230-T2021-06-07
07290110640705 T-Edge 11 AMS11-120-TAMS11-120-T2021-03-11
07290110640712T-Edge 11 AMS11-120-W-TAMS11-120-W-T2021-03-11
07290110640446T-Edge 10 T-Edge 10 AMS10-230-W-T2019-12-01
072901106407435596-1R-L-USA5596-1R Model5596-1R-L-USA2021-05-09
072901106407505596-1R-R-USA5596-1R Model5596-1R-R-USA2021-05-09
07290110640668Model 44724472-2V4472-2V2020-12-08
072901106406372540MKA2540MKATTA2540-1R23MKA2020-07-21
07290110640453Model 5596-1VModel 5596-1V5596-1V-L-USA2020-01-05

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