Ballancer Pro Pants (FB) - The Ballancer Pro Pants (FB) inflatable garment - MEGO afek Agricultural Cooperative Society Ltd

Duns Number:514658082

Device Description: The Ballancer Pro Pants (FB) inflatable garment is fills and deflates, applying a directio

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More Product Details

Catalog Number

L4MP4130C

Brand Name

Ballancer Pro Pants (FB)

Version/Model Number

Bal Pants (FB)

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

-

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

K013331

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

be7c34f0-6ba6-49e9-bf65-bf3568436cce

Public Version Date

January 01, 2020

Public Version Number

1

DI Record Publish Date

December 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEGO AFEK AGRICULTURAL COOPERATIVE SOCIETY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 100