Avaline Medical NJ LLC - 10 Sterile Stool Specimen Cup - Avaline Medical NJ Limited Liability Company

Duns Number:079767953

Device Description: 10 Sterile Stool Specimen Cup

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More Product Details

Catalog Number

STSC X10

Brand Name

Avaline Medical NJ LLC

Version/Model Number

STSC X10

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

ff281e45-76d6-4a48-bc3d-c04818b3bd57

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVALINE MEDICAL NJ LIMITED LIABILITY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 263