Duns Number:002144145
Device Description: Violet Polydioxanone Polymer, Synthetic Absorbable Suture Clips
Catalog Number
XC200
Brand Name
LAPRA-TY
Version/Model Number
XC200
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
K931492,K931492
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
697afb4f-ae68-4db1-86a3-9c2e20316027
Public Version Date
July 18, 2022
Public Version Number
6
DI Record Publish Date
September 25, 2015
Package DI Number
20705031206882
Quantity per Package
6
Contains DI Package
10705031206885
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |