Duns Number:071595540
Device Description: NAKAO SPIDER-NET RETRIEVAL DEVICE 230 L
Catalog Number
00230A
Brand Name
NAKAO
Version/Model Number
00230A
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)
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
f2113b4c-82d9-4c6c-abe5-22f62c581e0d
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
10653405054122
Quantity per Package
10
Contains DI Package
20653405054129
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 |