Good Neighbor Pharmacy - 5mm Pen Needle 100ct box - Amerisourcebergen Drug Corporation

Duns Number:007914906

Device Description: 5mm Pen Needle 100ct box

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More Product Details

Catalog Number

-

Brand Name

Good Neighbor Pharmacy

Version/Model Number

10231717

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

K100812,K152410,K100812,K152410,K100812,K152410

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

e9e90e4e-b827-442d-9796-8e59dc61358a

Public Version Date

August 08, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2019

Additional Identifiers

Package DI Number

20087701432624

Quantity per Package

12

Contains DI Package

00087701432620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"AMERISOURCEBERGEN DRUG CORPORATION" 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. 13