TRAUS SSG10 - Saeshin Precision Co., Ltd.

Duns Number:688019566

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More Product Details

Catalog Number

-

Brand Name

TRAUS SSG10

Version/Model Number

TRAUS TRT12NSH

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"

Yes

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

-

Product Code Details

Product Code

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Device Record Status

Public Device Record Key

a48d6e77-299b-4fc8-a6c3-6cf7ddf00c2a

Public Version Date

January 30, 2020

Public Version Number

1

DI Record Publish Date

January 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAESHIN PRECISION CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 91
2 A medical device with a moderate to high risk that requires special controls. 5