Kroger Insulin Syringes - .5cc 12.7mm 29G Insulin Syringe, Sterile, - KROGER CO., THE

Duns Number:006999528

Device Description: .5cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct

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More Product Details

Catalog Number

-

Brand Name

Kroger Insulin Syringes

Version/Model Number

052912

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 2018

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062702,K062702,K062702

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

b953e009-3e08-48b3-bd78-35475fcb30b8

Public Version Date

August 05, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10011110375039

Quantity per Package

30

Contains DI Package

00011110375032

Package Discontinue Date

August 07, 2018

Package Status

Not in Commercial Distribution

Package Type

Shipper

"KROGER CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 15