Globe Scientific - Inoculation Loop, Flexible, 1uL with Needle, - GLOBE SCIENTIFIC INC.

Duns Number:106793995

Device Description: Inoculation Loop, Flexible, 1uL with Needle, STERILE, Natural, 20/Peel Pack, 50 Packs/Unit

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More Product Details

Catalog Number

-

Brand Name

Globe Scientific

Version/Model Number

2801

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

LIB

Product Code Name

Device, General Purpose, Microbiology, Diagnostic

Device Record Status

Public Device Record Key

521eb25f-8805-410c-9de0-0e3266a60ee0

Public Version Date

December 08, 2021

Public Version Number

3

DI Record Publish Date

November 26, 2019

Additional Identifiers

Package DI Number

00840095604529

Quantity per Package

10

Contains DI Package

00840095604512

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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