Bipolar Forceps - Bipolar Forceps Kleppinger-Style BC 45CM - MECTRA LABS, INC.

Duns Number:606939072

Device Description: Bipolar Forceps Kleppinger-Style BC 45CM

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

0600-BC3320-000

Brand Name

Bipolar Forceps

Version/Model Number

0600-BC3320-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2020

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

HIN

Product Code Name

COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Device Record Status

Public Device Record Key

2c0153f1-475d-4c16-9926-5f3bfda27119

Public Version Date

January 13, 2020

Public Version Number

3

DI Record Publish Date

January 25, 2019

Additional Identifiers

Package DI Number

10817984010911

Quantity per Package

5

Contains DI Package

00817984010914

Package Discontinue Date

January 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Inner Pack

"MECTRA LABS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 57