STERiGLIDE TM - CANNULA - TSK LABORATORY, JAPAN

Duns Number:716217877

Device Description: CANNULA

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More Product Details

Catalog Number

-

Brand Name

STERiGLIDE TM

Version/Model Number

SGC-040038A

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

8274429d-6925-4a07-a86b-88fcb778a5c9

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

Additional Identifiers

Package DI Number

14571225317769

Quantity per Package

105

Contains DI Package

04571225317762

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TSK LABORATORY, JAPAN" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4