Duns Number:007941230
Device Description: Bouffant Cap 14 gsm Large Spunbonded Polypropylene Blue
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
69909
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
267bacf1-ba74-4c97-b1b0-5836ff3c40ae
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 04, 2021
Package DI Number
20885632284318
Quantity per Package
6
Contains DI Package
30885632284315
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 |