Duns Number:071595540
Device Description: OrthoVAC Orthopedic Yankauer Kit: 6 mm Yankauer, 11/32" (9 mm) x 12' (3.7 m) clear tubing OrthoVAC Orthopedic Yankauer Kit: 6 mm Yankauer, 11/32" (9 mm) x 12' (3.7 m) clear tubing and adapters
Catalog Number
0037001
Brand Name
OrthoVAC
Version/Model Number
0037001
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"
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
346f8efc-e0ed-4ee3-9751-2b00614c652a
Public Version Date
October 13, 2021
Public Version Number
1
DI Record Publish Date
October 05, 2021
Package DI Number
30653405986359
Quantity per Package
1
Contains DI Package
20653405986352
Package Discontinue Date
-
Package Status
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 |