Duns Number:604056226
Device Description: Retrieval Net, 1.8mm Diam, 1600mm L, 30mm (Net) W, 25mm (Net) H
Catalog Number
-
Brand Name
Key Surgical Foreign Body Retrievers
Version/Model Number
EN10178B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2022
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
-
Product Code
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
0a7d539a-5ce1-4da2-aff5-e93f0e15cb3d
Public Version Date
February 25, 2022
Public Version Number
5
DI Record Publish Date
August 05, 2020
Package DI Number
00849771041115
Quantity per Package
10
Contains DI Package
00849771039907
Package Discontinue Date
December 03, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |