Duns Number:021717889
Device Description: Clip
Catalog Number
M00521400
Brand Name
Resolution 360™ ULTRA Clip
Version/Model Number
M00521400
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"
-
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
PKL
Product Code Name
Hemostatic metal clip for the GI tract
Public Device Record Key
259af2bd-198e-4df0-a389-15677dd6067e
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
December 07, 2020
Package DI Number
08714729997252
Quantity per Package
10
Contains DI Package
08714729997245
Package Discontinue Date
-
Package Status
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |