Needle, Hypodermic, Single Lumen - MPS MEDICAL, INC

Duns Number:079636164

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More Product Details

Catalog Number

-

Brand Name

Needle, Hypodermic, Single Lumen

Version/Model Number

900490

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"

Yes

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

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

acbe3d30-8452-4e5c-ba21-0c83a15a94e4

Public Version Date

October 23, 2019

Public Version Number

7

DI Record Publish Date

May 26, 2016

Additional Identifiers

Package DI Number

10816513020292

Quantity per Package

500

Contains DI Package

00816513020295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"MPS MEDICAL, INC" 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. 148