Plasma-Cel Short Pocket with Belts Multi-pouch - Plasma-Cel Short Pocket with Belts Multi-pouch 11 - CYGNUS MEDICAL L.L.C.

Duns Number:103169095

Device Description: Plasma-Cel Short Pocket with Belts Multi-pouch 11 in. x 15-1/2 in. - 25 Multi-pouches

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More Product Details

Catalog Number

-

Brand Name

Plasma-Cel Short Pocket with Belts Multi-pouch

Version/Model Number

PC5200

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

05a94627-8c0d-4bc9-aa16-ed7d290ed5b2

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

10843356101482

Quantity per Package

2

Contains DI Package

00843356101485

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