CONMED - American Dilator, 57 F - Conmed Corporation

Duns Number:071595540

Device Description: American Dilator, 57 F

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More Product Details

Catalog Number

000287

Brand Name

CONMED

Version/Model Number

000287

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)

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

KNQ

Product Code Name

Dilator, esophageal

Device Record Status

Public Device Record Key

289df491-9a5e-4db6-bdeb-95dcc861e172

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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