ACU-NEEDLE - 31 fine gauge 1/2" needle, high quality - ACUDERM, INC.

Duns Number:071426803

Device Description: 31 fine gauge 1/2" needle, high quality economical plastic hub hypodermic needles. Fits b 31 fine gauge 1/2" needle, high quality economical plastic hub hypodermic needles. Fits both luer slip and luer lock syringes, tri-beveled tip. Sterile

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More Product Details

Catalog Number

-

Brand Name

ACU-NEEDLE

Version/Model Number

NP315

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K874024,K874024

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

e41fe056-5b37-45b3-9b69-b75863b816f4

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUDERM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 61