Batrik Brush Universal Single End 11mm - Brush Universal Single End 11mm - Single use - Batrik Medical Manufacturing Inc

Duns Number:243880700

Device Description: Brush Universal Single End 11mm - Single use

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More Product Details

Catalog Number

27-15311

Brand Name

Batrik Brush Universal Single End 11mm

Version/Model Number

27-15311

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)

-

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

8e2cf3f5-d175-438b-8606-5f1c57e0ff26

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BATRIK MEDICAL MANUFACTURING INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 748
2 A medical device with a moderate to high risk that requires special controls. 20