Medegen Medical products - STACKABLE CONTAINER 1 GALLON TRANSLUCENT YELLOW - MEDEGEN MEDICAL PRODUCTS, LLC

Duns Number:055527753

Device Description: STACKABLE CONTAINER 1 GALLON TRANSLUCENT YELLOW W/FLAT LID

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

8703TYV

Brand Name

Medegen Medical products

Version/Model Number

8703TYV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K942054,K942054

Product Code Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

04845760-b050-48e1-8fd2-013f57cf89a5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 11, 2017

Additional Identifiers

Package DI Number

H3628703TYV2B

Quantity per Package

24

Contains DI Package

H3628703TYV09

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDEGEN MEDICAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 108