AED - Sinus Curved Right Scissor #501.09A - NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Duns Number:839138955

Device Description: Sinus Curved Right Scissor #501.09A

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More Product Details

Catalog Number

-

Brand Name

AED

Version/Model Number

501.09A

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

KBD

Product Code Name

SCISSORS, NASAL

Device Record Status

Public Device Record Key

b2952b31-9932-4e36-9c93-5b65c37e65a2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATIONAL ADVANCED ENDOSCOPY DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 579
2 A medical device with a moderate to high risk that requires special controls. 6418