MEDI - JUXTA-FIT ARM 2-LEFT (48CM) LONG - MEDI MANUFACTURING, INC.

Duns Number:960754430

Device Description: JUXTA-FIT ARM 2-LEFT (48CM) LONG

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


More Product Details

Catalog Number

-

Brand Name

MEDI

Version/Model Number

06220828

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2020

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"

-

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

MDR

Product Code Name

BINDER, MEDICAL, THERAPEUTIC

Device Record Status

Public Device Record Key

8b01d016-0497-47a3-b7a6-9efb9fc38b59

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDI MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2971
2 A medical device with a moderate to high risk that requires special controls. 9550