Black Eye - The Standard Co., Ltd.

Duns Number:557812775

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More Product Details

Catalog Number

-

Brand Name

Black Eye

Version/Model Number

TS-205

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NBG

Product Code Name

Marker, Colon

Device Record Status

Public Device Record Key

f7d3ccf1-47cc-4d40-9e2a-a083f4c9d80d

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

January 18, 2019

Additional Identifiers

Package DI Number

08809380050771

Quantity per Package

12

Contains DI Package

08809380059002

Package Discontinue Date

July 07, 2021

Package Status

Not in Commercial Distribution

Package Type

Canister