Duns Number:961027315
Device Description: Ortho Convertor 10/Box
Catalog Number
65652-119
Brand Name
MEDI-VAC
Version/Model Number
65652-119
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)
-
Over the Counter (OTC)
Yes
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
81688e14-f7a1-45a0-9174-7ebb4b7380b2
Public Version Date
July 23, 2018
Public Version Number
3
DI Record Publish Date
March 06, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |