Duns Number:025460908
Device Description: 8773A C-REAMER DRL BIT,SHRT HEAD 10MM
Catalog Number
8773AR
Brand Name
Medline
Version/Model Number
8773AR
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
-
Product Code
HTO
Product Code Name
REAMER
Public Device Record Key
e348895f-07f6-49a1-92aa-6e2524d226c9
Public Version Date
May 20, 2022
Public Version Number
1
DI Record Publish Date
May 12, 2022
Package DI Number
20888277384184
Quantity per Package
4
Contains DI Package
10888277384187
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 |