Keenhealth - K-MB-716 is an Adjustable maternity Belt - Sevenground Trading B.V.

Duns Number:492177197

Device Description: K-MB-716 is an Adjustable maternity Belt

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More Product Details

Catalog Number

-

Brand Name

Keenhealth

Version/Model Number

K-MB-716

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IQE

Product Code Name

Orthosis, Lumbar

Device Record Status

Public Device Record Key

1cc57c32-aa5c-4d60-83fa-84f2546594a4

Public Version Date

October 07, 2019

Public Version Number

2

DI Record Publish Date

May 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEVENGROUND TRADING B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 53