Duns Number:058614483
Device Description: Monofilament Polypropylene, P-12, 1x Blue Strand
Catalog Number
SP5686GMDL
Brand Name
Surgipro II
Version/Model Number
SP5686GMDL
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
73e82029-b11b-4043-8dce-ff2b958d4c85
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884521212371
Quantity per Package
12
Contains DI Package
10884521212374
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 |