A&E Medical / Disposable Laparoscopic Cords - Disposable Laparoscopic Cords, 1 per pouch - A & E MEDICAL CORPORATION

Duns Number:173770868

Device Description: Disposable Laparoscopic Cords, 1 per pouch

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More Product Details

Catalog Number

-

Brand Name

A&E Medical / Disposable Laparoscopic Cords

Version/Model Number

050-300

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K930528,K930528

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

0a53d50d-c962-45fe-8f9d-17fc9cd3edf5

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

December 01, 2016

Additional Identifiers

Package DI Number

20841291105098

Quantity per Package

50

Contains DI Package

10841291105091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"A & E MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 621