Duns Number:009831413
Device Description: PA CAP BOUFFANT 24 WHT 100/BX 5BX/CS
Catalog Number
P701020
Brand Name
PRO ADVANTAGE
Version/Model Number
P701020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYF
Product Code Name
Cap, Surgical
Public Device Record Key
8b07b9a3-996c-4d0a-a0cf-6eb4122802d1
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
October 02, 2022
Package DI Number
M220P7010205
Quantity per Package
5
Contains DI Package
M220P7010203
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 | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |