MEDI - JUXTAFIT BASIC LOWER LEG 36CM MEDIUM - MEDI MANUFACTURING, INC.

Duns Number:960754430

Device Description: JUXTAFIT BASIC LOWER LEG 36CM MEDIUM

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More Product Details

Catalog Number

-

Brand Name

MEDI

Version/Model Number

70524000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

f3f0a6ae-0dc9-41c4-9faf-026a4905de0b

Public Version Date

June 10, 2022

Public Version Number

2

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