Bella Lite Glove - BELLA LITE 15-20 MM HG GLOVES SIZE 6 BEIGE 1 UPC - BSN MEDICAL, INC.

Duns Number:026301221

Device Description: BELLA LITE 15-20 MM HG GLOVES SIZE 6 BEIGE 1 UPC

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More Product Details

Catalog Number

-

Brand Name

Bella Lite Glove

Version/Model Number

7769705

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

-

Product Code Details

Product Code

MDR

Product Code Name

BINDER, MEDICAL, THERAPEUTIC

Device Record Status

Public Device Record Key

71ba53a2-2c5f-4ba9-aa72-2a6287de11c5

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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