GlobeScientific - Specimen bag, glue seal, 6x9" absorbent pad & - GLOBE SCIENTIFIC INC.

Duns Number:106793995

Device Description: Specimen bag, glue seal, 6x9" absorbent pad & doc. pouch

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More Product Details

Catalog Number

-

Brand Name

GlobeScientific

Version/Model Number

4923

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

NNI

Product Code Name

Container, Specimen, Non-Sterile

Device Record Status

Public Device Record Key

f640494c-0808-4379-bd09-e6731199ec75

Public Version Date

January 28, 2022

Public Version Number

2

DI Record Publish Date

December 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBE SCIENTIFIC INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 184
2 A medical device with a moderate to high risk that requires special controls. 3