TopCare Clickfine Pen Needles - Sterile, single-use, 6-bevel pen needles, 31 - TOPCO ASSOCIATES, LLC

Duns Number:072943876

Device Description: Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length

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More Product Details

Catalog Number

-

Brand Name

TopCare Clickfine Pen Needles

Version/Model Number

700001340

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

8f73243c-b697-4373-98f5-a6f2b3548260

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10036800250915

Quantity per Package

20

Contains DI Package

00036800250918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"TOPCO ASSOCIATES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 1