Bosma Enterprises - Accelerate-OR Dental SED Kit; Each Kit Includes - Bosma Enterprises

Duns Number:878070325

Device Description: Accelerate-OR Dental SED Kit; Each Kit Includes 40x40 Red Infectious Waste 2 mil Draw Tape Accelerate-OR Dental SED Kit; Each Kit Includes 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 38x38 Clear 1.5 mil Draw Cord Bag (4) and 24x24 Red Liner 1.2 mil 10 gal Bag (2).

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More Product Details

Catalog Number

10-8020SED

Brand Name

Bosma Enterprises

Version/Model Number

10-8020SED

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

PWU

Product Code Name

Clean-Up Kit

Device Record Status

Public Device Record Key

05c2340f-b204-4a47-b989-1cc99c860740

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Additional Identifiers

Package DI Number

10818634020809

Quantity per Package

12

Contains DI Package

00818634020802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BOSMA ENTERPRISES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72