Duns Number:830016148
Device Description: IP-310 Nexcare(TM) Earloop Mask , 3 ct
Catalog Number
IP310
Brand Name
Nexcare™
Version/Model Number
IP310
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"
-
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
FXX
Product Code Name
Mask, surgical
Public Device Record Key
eab27aab-9f2c-4ab0-b094-c24fa94814d3
Public Version Date
March 11, 2021
Public Version Number
3
DI Record Publish Date
July 21, 2016
Package DI Number
30051131197917
Quantity per Package
6
Contains DI Package
00051131197916
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |