Duns Number:058614483
Device Description: Monofilament Polypropylene, P-11, 1x Blue Strand
Catalog Number
SP5687GMDL
Brand Name
Surgipro II
Version/Model Number
SP5687GMDL
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
K010909,K010909
Product Code
GAW
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Public Device Record Key
7403e668-a8dd-4141-b43d-8641ccae7aa5
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
January 07, 2017
Package DI Number
20884521215884
Quantity per Package
12
Contains DI Package
10884521215887
Package Discontinue Date
-
Package Status
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 |