JOBST Bella - BELLA STRONG 15-20 MM HG GLOVES SIZE 2 BLACK 1 - BSN MEDICAL, INC.

Duns Number:026301221

Device Description: BELLA STRONG 15-20 MM HG GLOVES SIZE 2 BLACK 1

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More Product Details

Catalog Number

7520031

Brand Name

JOBST Bella

Version/Model Number

7520031

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

3bdb1c45-c3ee-40de-91a8-c00dbb37318b

Public Version Date

May 19, 2022

Public Version Number

5

DI Record Publish Date

August 21, 2017

Additional Identifiers

Package DI Number

00035664026127

Quantity per Package

10

Contains DI Package

00035664025663

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BSN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 3716