Duns Number:961027315
Device Description: Devon Surgical Site Mini-Marker Prep Resistant
Catalog Number
31146020
Brand Name
Devon
Version/Model Number
31146020
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
FZZ
Product Code Name
MARKER, SKIN
Public Device Record Key
93e70d2c-7490-46e0-8cfb-48261f29e30a
Public Version Date
September 29, 2021
Public Version Number
1
DI Record Publish Date
September 21, 2021
Package DI Number
50192253021248
Quantity per Package
2
Contains DI Package
20192253021247
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |