Duns Number:071595540
Device Description: Orthopedic Yankauer Kit, Straight, US
Catalog Number
0035001
Brand Name
ORTHOVAC
Version/Model Number
0035001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 24, 2021
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"
Yes
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
GCX
Product Code Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Public Device Record Key
f5f83986-a84f-46cd-b50e-d957c750d2b6
Public Version Date
May 25, 2021
Public Version Number
4
DI Record Publish Date
October 31, 2018
Package DI Number
30653405986304
Quantity per Package
10
Contains DI Package
20653405986307
Package Discontinue Date
May 24, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |