9000 Series Disposable Channel Cleaning Brush - Disposable Suction Well & Valve Double Ended - Primed Instruments Inc

Duns Number:254491293

Device Description: Disposable Suction Well & Valve Double Ended Cleaning Brush. HIBC/UPN: M45399923

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More Product Details

Catalog Number

9992

Brand Name

9000 Series Disposable Channel Cleaning Brush

Version/Model Number

9992

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Device Record Status

Public Device Record Key

40626997-70ca-4951-9dee-8504dd6931f4

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIMED INSTRUMENTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40