Duns Number:103977526
Device Description: Nylon bag (55 x 108cm, 14L) for wingboard with headrest pocket
Catalog Number
VLWGB05C
Brand Name
Vac-Lok™ Cushion
Version/Model Number
VLWGB05C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K180021
Product Code
IXQ
Product Code Name
Table, radiographic, stationary top
Public Device Record Key
7445b6b9-fdd3-458e-b671-96fedcc8c8c3
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
November 05, 2020
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1027 |