B&B Monopolar Dissector - B&B E-P ELECTROSURGICAL DISSECTOR; - BLACK & BLACK SURGICAL, INC.

Duns Number:004382282

Device Description: B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT TIP (1 PAI B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT TIP (1 PAIR)

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More Product Details

Catalog Number

B65227

Brand Name

 B&B Monopolar Dissector

Version/Model Number

B65227

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072124

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

cf714b61-17e4-47a0-bdc2-dcce516ce49b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLACK & BLACK SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5533
2 A medical device with a moderate to high risk that requires special controls. 240