Duns Number:079720472
Device Description: Acusnare Polypectomy Snare Needle Tip
Catalog Number
AS-1NT-S
Brand Name
Acusnare
Version/Model Number
G22897
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 10, 2021
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
KNS
Product Code Name
Unit, electrosurgical, endoscopic (with or without accessories)
Public Device Record Key
7ac072c2-08a9-48f8-bc88-a3830dc1dca7
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10827002228976
Quantity per Package
10
Contains DI Package
00827002228979
Package Discontinue Date
May 10, 2021
Package Status
Not 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 | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |