Duns Number:025460908
Device Description: AR-8380SR COOLCUT SABRE BLUE/GREEN 3.
Catalog Number
AR8380SRR
Brand Name
Medline
Version/Model Number
AR8380SRR
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113028,K113028
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
2b299537-f7b7-49bf-a5cb-1790fc6a8936
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
May 12, 2022
Package DI Number
20888277389028
Quantity per Package
5
Contains DI Package
10888277389021
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 |