Globe Scientific - ACE: Sample Cup, for use with the Schiapparelli - GLOBE SCIENTIFIC INC.

Duns Number:106793995

Device Description: ACE: Sample Cup, for use with the Schiapparelli ACE analyzer

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More Product Details

Catalog Number

-

Brand Name

Globe Scientific

Version/Model Number

5545

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

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Record Status

Public Device Record Key

4c90f5bb-b580-4428-8b74-ca98fecccc74

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2019

Additional Identifiers

Package DI Number

00840095607933

Quantity per Package

12

Contains DI Package

00840095607926

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