TRAUS SUS10 - 92.7(L) x 20.0(D) - Saeshin Precision Co., Ltd.

Duns Number:688019566

Device Description: 92.7(L) x 20.0(D)

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More Product Details

Catalog Number

-

Brand Name

TRAUS SUS10

Version/Model Number

TRAUS CRB26LX

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

-

Product Code Details

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Device Record Status

Public Device Record Key

572065d7-9a24-4e20-9516-ff9c935e5942

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

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