Gel Cord Topical Hemostatic Gel ProPack - 25% aluminum sulfate gel; 25 - 0.75g syringes - PASCAL COMPANY, INC.

Duns Number:009260217

Device Description: 25% aluminum sulfate gel; 25 - 0.75g syringes

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More Product Details

Catalog Number

15540

Brand Name

Gel Cord Topical Hemostatic Gel ProPack

Version/Model Number

15540

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)

Yes

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

MVL

Product Code Name

Cord, Retraction

Device Record Status

Public Device Record Key

8dd950c8-3729-493d-983a-c6034ffb618a

Public Version Date

March 01, 2019

Public Version Number

1

DI Record Publish Date

January 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PASCAL COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34
2 A medical device with a moderate to high risk that requires special controls. 6
U Unclassified 57