Duns Number:025460908
Device Description: DBD-CAP,BOUFFANT,MULTICOLOR,HVY WT,24"
Catalog Number
NON28234P
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
NON28234P
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
FXP
Product Code Name
COVER, SHOE, OPERATING-ROOM
Public Device Record Key
4f29d6aa-557d-49b5-9ee2-9d80d9de5a6f
Public Version Date
April 14, 2022
Public Version Number
1
DI Record Publish Date
April 06, 2022
Package DI Number
40080196752158
Quantity per Package
500
Contains DI Package
30080196752151
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 | 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 |