Duns Number:962519208
Device Description: Olympic Vac-Pac Disposable Cover Size 32
Catalog Number
VPC32
Brand Name
Olympic Vac-Pac
Version/Model Number
Disposable Cover Size 32
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
139be2ff-b00b-44d7-a8e0-c8dd2a21ea1f
Public Version Date
January 10, 2020
Public Version Number
1
DI Record Publish Date
January 02, 2020
Package DI Number
00382830057790
Quantity per Package
30
Contains DI Package
00382830057530
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 |