Single Use Combination Cleaning Brush - BW-412T DISP COMBO CLEANING BRUSH - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

Device Description: BW-412T DISP COMBO CLEANING BRUSH

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More Product Details

Catalog Number

-

Brand Name

Single Use Combination Cleaning Brush

Version/Model Number

BW-412T

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

54d7cb18-2755-4b14-b810-c4eb147b3ce6

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

54953170297422

Quantity per Package

4

Contains DI Package

04953170297427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OLYMPUS MEDICAL SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 1962
U Unclassified 52