Plasti Products - Specimen Container, non-sterile - PLASTI-PRODUCTS INC

Duns Number:153880372

Device Description: Specimen Container, non-sterile

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More Product Details

Catalog Number

1150

Brand Name

Plasti Products

Version/Model Number

PlastiGrad, 200cc

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

b5011d55-f802-4212-94bb-4ec40deb0d1d

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

April 15, 2016

Additional Identifiers

Package DI Number

40797876111500

Quantity per Package

200

Contains DI Package

10797876111509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"PLASTI-PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 17