Duns Number:071595540
Device Description: Spider Net Standard Net 5 pack
Catalog Number
0230AM
Brand Name
SPIDER-NET
Version/Model Number
0230AM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FGX
Product Code Name
SNARE, NON-ELECTRICAL
Public Device Record Key
e59eecce-704b-4413-b1a5-f64ed6426b92
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
April 28, 2020
Package DI Number
10653405054115
Quantity per Package
20
Contains DI Package
20653405054112
Package Discontinue Date
-
Package Status
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |