Duns Number:962519208
Device Description: Olympic Vac-Pac Disposable Cover Size 30
Catalog Number
VPC30
Brand Name
Olympic Vac-Pac
Version/Model Number
Disposable Cover Size 30
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
-
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
0a740613-1e35-40b1-b1f2-5a8ee9b67c81
Public Version Date
January 10, 2020
Public Version Number
1
DI Record Publish Date
January 02, 2020
Package DI Number
00382830057806
Quantity per Package
30
Contains DI Package
00382830057516
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |