Procedure Products Lines - HIGH PRESSURE BRAIDED SWIVEL LINE, 10" - PROCEDURE PRODUCTS, INC.

Duns Number:151507563

Device Description: HIGH PRESSURE BRAIDED SWIVEL LINE, 10"

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More Product Details

Catalog Number

-

Brand Name

Procedure Products Lines

Version/Model Number

B10-R072

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K914128

Product Code Details

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Device Record Status

Public Device Record Key

03d89233-8d29-4e1b-a630-091f229bb7e6

Public Version Date

May 01, 2020

Public Version Number

1

DI Record Publish Date

April 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROCEDURE PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 98