Eco Fit - Eco Fit Needle Holder, Self Righting, 5mm, 33cm - NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Duns Number:839138955

Device Description: Eco Fit Needle Holder, Self Righting, 5mm, 33cm

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More Product Details

Catalog Number

-

Brand Name

Eco Fit

Version/Model Number

B1592SR

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

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

NWV

Product Code Name

Laparoscopic accessories, gynecologic

Device Record Status

Public Device Record Key

0e662621-07bc-42a8-9970-fda0c0434f65

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

April 26, 2018

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