Duns Number:058614483
Device Description: Clip Applier with Polysorb Clips
Catalog Number
-
Brand Name
Poly Surgiclip
Version/Model Number
133649
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2022
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
K900122,K900122
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
1fa7c8b1-daa4-4e3c-ad3c-edf4826c61a0
Public Version Date
October 12, 2022
Public Version Number
6
DI Record Publish Date
August 28, 2015
Package DI Number
20884521133676
Quantity per Package
12
Contains DI Package
10884521133679
Package Discontinue Date
April 22, 2022
Package Status
Not 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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |