Duns Number:007941230
Device Description: Cap Bouffant Lightweight Spunbond Polypropylene Blue 24 Inch Non-Sterile Disposable Not Ma Cap Bouffant Lightweight Spunbond Polypropylene Blue 24 Inch Non-Sterile Disposable Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
77702
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)
Yes
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
daea7ef1-a335-4fe2-97f7-f295a6384962
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
October 06, 2020
Package DI Number
50885632105287
Quantity per Package
5
Contains DI Package
30885632105283
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |