BR Surgical, LLC - Cystoscope, autoclavable, Ø 4mm, 12º, 302mm - BR Surgical, LLC

Duns Number:134781207

Device Description: Cystoscope, autoclavable, Ø 4mm, 12º, 302mm

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More Product Details

Catalog Number

BR966-4012-302

Brand Name

BR Surgical, LLC

Version/Model Number

BR966-4012-302

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FAJ

Product Code Name

Cystoscope and accessories, flexible/rigid

Device Record Status

Public Device Record Key

2546cb5c-8a14-4863-a533-46ec33023a9f

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BR SURGICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 34