Duns Number:812762226
Device Description: 2xHRS-13.0-300 USP 5-0 Polypropylene blue 75 cm Pledget 3x3. sterile VA9.8
Catalog Number
E112PP2
Brand Name
FSSB
Version/Model Number
E112PP2
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
K131224,K131224
Product Code
GAW
Product Code Name
Suture, nonabsorbable, synthetic, polypropylene
Public Device Record Key
e6a5688f-dacb-4d47-8312-ce4421190efe
Public Version Date
August 29, 2022
Public Version Number
2
DI Record Publish Date
October 22, 2021
Package DI Number
10848782042675
Quantity per Package
24
Contains DI Package
00848782042678
Package Discontinue Date
-
Package Status
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 | 300 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
| U | Unclassified | 19 |