Duns Number:831375089
Device Description: PremierPro Bouffant Cap Lightweight, Green, 24", 100/bx
Catalog Number
2151
Brand Name
PremierPro
Version/Model Number
2151
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"
Yes
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
455923c0-55bb-42ba-9c58-7c92e5b78fce
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
July 25, 2020
Package DI Number
10854344002766
Quantity per Package
5
Contains DI Package
00854344002769
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |