Plasma-Cel Large Single Pouch - Plasma-Cel Large Single Pouch - 4 in. x 7 in. - - CYGNUS MEDICAL L.L.C.

Duns Number:103169095

Device Description: Plasma-Cel Large Single Pouch - 4 in. x 7 in. - 25 Large Single Pouches

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More Product Details

Catalog Number

-

Brand Name

Plasma-Cel Large Single Pouch

Version/Model Number

PC6210

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

LRP

Product Code Name

Tray, Surgical

Device Record Status

Public Device Record Key

4508fe2a-c81b-487b-8050-165dd88aeb52

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

10843356101529

Quantity per Package

8

Contains DI Package

00843356101522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CYGNUS MEDICAL L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 146