Catalog Number

-

Brand Name

MEDI

Version/Model Number

70015000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2020

Issuing Agency

In GS1

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

MDR

Product Code Name

BINDER, MEDICAL, THERAPEUTIC

Public Device Record Key

a522358e-361b-4b52-8d79-72309b7d400b

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-