Duns Number:809152916
Device Description: Plexus Handpiece O-Rings (10 Pack) - Lowest available count never sold individually. Cons Plexus Handpiece O-Rings (10 Pack) - Lowest available count never sold individually. Considered an "each".
Catalog Number
A0176
Brand Name
Plexus Handpiece O-Rings
Version/Model Number
A0176
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFE
Product Code Name
Brush, Dermabrasion, Powered
Public Device Record Key
4b7827e9-769e-4edc-bd75-2ac0007bc17e
Public Version Date
March 29, 2021
Public Version Number
1
DI Record Publish Date
March 19, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 129 |