Duns Number:058614483
Device Description: Monofilament Polypropylene, MVF-17509, D/A, 2x Blue Strands
Catalog Number
-
Brand Name
Surgipro II
Version/Model Number
VP760MX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 10, 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
K010909,K010909
Product Code
GAW
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Public Device Record Key
9d481e48-7e7f-46bd-a6e3-aebb08ca4150
Public Version Date
October 13, 2022
Public Version Number
9
DI Record Publish Date
January 06, 2017
Package DI Number
20884521215150
Quantity per Package
12
Contains DI Package
10884521215153
Package Discontinue Date
October 10, 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 |