Procedure Products Needles - NEEDLE, 2 PART, 10.2cm, 18g, MODIFIED POTTS - PROCEDURE PRODUCTS, INC.

Duns Number:151507563

Device Description: NEEDLE, 2 PART, 10.2cm, 18g, MODIFIED POTTS

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More Product Details

Catalog Number

20-1840

Brand Name

Procedure Products Needles

Version/Model Number

20-1840

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

Product Code Details

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Device Record Status

Public Device Record Key

71e5825f-6078-470f-9a5d-5d8f76140c2a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 02, 2018

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