Duns Number:058614483
Device Description: Monofilament Polypropylene
Catalog Number
-
Brand Name
Surgipro II
Version/Model Number
X1379
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 12, 2021
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
K954808,K954808
Product Code
GAW
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Public Device Record Key
cc0bc4f9-9251-4a97-ae69-54f8b960aeba
Public Version Date
August 12, 2022
Public Version Number
10
DI Record Publish Date
October 11, 2017
Package DI Number
20884521584621
Quantity per Package
36
Contains DI Package
10884521584624
Package Discontinue Date
February 12, 2021
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |