PRECISOR - PRECISOR XL COATED DISPOSABLE BIOPSY FORCEPS, 230 - Conmed Corporation

Duns Number:071595540

Device Description: PRECISOR XL COATED DISPOSABLE BIOPSY FORCEPS, 230 CM

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


More Product Details

Catalog Number

00389B

Brand Name

PRECISOR

Version/Model Number

00389B

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

-

Product Code Details

Product Code

FCL

Product Code Name

FORCEPS, BIOPSY, NON-ELECTRIC

Device Record Status

Public Device Record Key

0ea60ea6-7165-4ff4-9d26-a608767d5ecb

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

20653405063855

Quantity per Package

50

Contains DI Package

10653405063858

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