AboutTime 31G x 5mm Pen Needles - 31G x 5mm Pen Needles. Universal fit - Medical Plastic Devices M.P.D. Inc

Duns Number:244897773

Device Description: 31G x 5mm Pen Needles. Universal fit

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More Product Details

Catalog Number

P4525

Brand Name

AboutTime 31G x 5mm Pen Needles

Version/Model Number

1

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)

Yes

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

09112bf5-6485-46e4-a5eb-062779743414

Public Version Date

March 03, 2020

Public Version Number

1

DI Record Publish Date

February 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL PLASTIC DEVICES M.P.D. INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7