1730 Valueklave - Sterilizer,steam - TUTTNAUER ISRAEL LTD.

Duns Number:600030209

Device Description: Sterilizer,steam

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More Product Details

Catalog Number

TTA1730-1R15VAL

Brand Name

1730 Valueklave

Version/Model Number

1730 Valueklave

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K833837

Product Code Details

Product Code

FLE

Product Code Name

Sterilizer, Steam

Device Record Status

Public Device Record Key

9d9126a5-19ae-493a-8166-d57c1def686f

Public Version Date

October 17, 2018

Public Version Number

1

DI Record Publish Date

September 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TUTTNAUER ISRAEL LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 70