Procedure Products Needle - NEEDLE, W/O BASEPLATE 5.7CM 18g - PROCEDURE PRODUCTS, INC.

Duns Number:151507563

Device Description: NEEDLE, W/O BASEPLATE 5.7CM 18g

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Procedure Products Needle

Version/Model Number

31-1822

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

K810859,K810859

Product Code Details

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Device Record Status

Public Device Record Key

83f089a7-9a4f-4053-bc3f-c4e5d5b5ace4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 07, 2017

Additional Identifiers

Package DI Number

B1603118222

Quantity per Package

25

Contains DI Package

B1603118221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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