PPS PI - Pressure Injectable Safety Huber Needle - PEROUSE MEDICAL

Duns Number:267476323

Device Description: Pressure Injectable Safety Huber Needle

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More Product Details

Catalog Number

-

Brand Name

PPS PI

Version/Model Number

U201907

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K120261,K120261

Product Code Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

934b575f-411f-4e17-87a9-00e9b9b253b0

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

13661234011176

Quantity per Package

12

Contains DI Package

03661234011179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

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