FDA.reportPublic FDA data

69120

Primary DI
00729011064035
Brand
69120
Company
TUTTNAUER ISRAEL LTD.
Model
69120-2A
Catalog number
69120-2A
Device description
Sterilizer,steam
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
false
Single use
false

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
K063711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063711000TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HATuttnauer Co. , Ltd.2007-02-02FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00729011064035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00729011064035007290110640357290110640350729011064035

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07290110640439T-Edge 10T-Edge 10AMS10-230-T2019-11-27
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

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