ELITE - ELITE Needle Holder, Curved Left, 5mm, 45cm - NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Duns Number:839138955

Device Description: ELITE Needle Holder, Curved Left, 5mm, 45cm

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More Product Details

Catalog Number

-

Brand Name

ELITE

Version/Model Number

ETH1593-45

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

38b6966e-c40d-4c45-b6ff-5ebf82d1228d

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