Duns Number:173770868
Device Description: Disposable Laparoscopic Cords, 1 per pouch
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
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
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
Package DI Number
20841291105098
Quantity per Package
50
Contains DI Package
10841291105091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
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 |