NA - 5MM X 32CM METZENBAUM BLADE MONOPOLAR - Conmed Corporation

Duns Number:071595540

Device Description: 5MM X 32CM METZENBAUM BLADE MONOPOLAR LAPAROSCOPIC SCISSORS

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More Product Details

Catalog Number

60-6035-431

Brand Name

NA

Version/Model Number

60-6035-431

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

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

K943327,K943327,K943327

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

05377257-ff7d-4de2-9f6d-9d3fb66e8862

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20653405039782

Quantity per Package

5

Contains DI Package

30653405039789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95