Duns Number:627879687
Device Description: The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placemen The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation.
Catalog Number
00711884
Brand Name
Assurance
Version/Model Number
00711884
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
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
K172727,K172727
Product Code
PKL
Product Code Name
Hemostatic metal clip for the GI tract
Public Device Record Key
4fa3e0b0-1180-44d4-a2af-108e6f95c212
Public Version Date
July 30, 2021
Public Version Number
1
DI Record Publish Date
July 22, 2021
Package DI Number
10724995215801
Quantity per Package
10
Contains DI Package
00724995215804
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |