Medegen Medical products - STACKABLE CONTAINER 1 GALLON W/FLAT LID - MEDEGEN MEDICAL PRODUCTS, LLC

Duns Number:055527753

Device Description: STACKABLE CONTAINER 1 GALLON W/FLAT LID

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More Product Details

Catalog Number

8703T

Brand Name

Medegen Medical products

Version/Model Number

8703T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2020

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

38369603-9986-49db-9534-d1d157dcccdb

Public Version Date

June 01, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

H3628703T2

Quantity per Package

24

Contains DI Package

H3628703T0

Package Discontinue Date

June 01, 2020

Package Status

Not 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