Duns Number:005085972
Device Description: 4-0 UNDYED PGAFA SUTURE 18", C-6 NEEDLE 18.7 MM, 3/8 CIRCLE REVERSE CUT
Catalog Number
PSN535FA
Brand Name
Hu-Friedy Mfg. Co., LLC
Version/Model Number
PSN535FA
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
-
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
c8028f3d-fac1-475c-8b1c-2f7d046bfe54
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 16, 2015
Package DI Number
10889950001025
Quantity per Package
3
Contains DI Package
10889950001452
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7436 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |