Duns Number:812762226
Device Description: PDO 4-0 Violet 1x18" P-3
Catalog Number
-
Brand Name
Sharpoint Plus
Version/Model Number
R494N
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
-
Product Code
NEW
Product Code Name
SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Public Device Record Key
cc2f1926-4189-4076-bf54-8ab271a4a907
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
February 19, 2019
Package DI Number
10848782033048
Quantity per Package
12
Contains DI Package
00848782033041
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 | 300 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
| U | Unclassified | 19 |