Duns Number:829465157
Device Description: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
Catalog Number
EPM8706G
Brand Name
PROLENE
Version/Model Number
EPM8706G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 27, 2018
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
K133356,K133356
Product Code
GAW
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Public Device Record Key
db533f81-94a6-47b5-a5a6-9dfb8fc6a230
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
June 04, 2018
Package DI Number
30705031242566
Quantity per Package
12
Contains DI Package
10705031242562
Package Discontinue Date
July 27, 2018
Package Status
Not 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |