Duns Number:025460908
Device Description: DBD-CAP,BOUFFANT,BUTTERFLY PRINT,24"
Catalog Number
NON28233F
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
NON28233F
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
8a5cd0e8-021d-4f82-96fd-a036bd56f48a
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
May 20, 2021
Package DI Number
30080196751963
Quantity per Package
100
Contains DI Package
10080196751969
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |