Duns Number:103977526
Device Description: 75 x 100cm, 21L, nylon bag for pelvic positioning
Catalog Number
VLPLV09C
Brand Name
Vac-Lok™ Cushion
Version/Model Number
VLPLV09C
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
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
51f7db7c-ced9-4feb-b488-77ca75312ca3
Public Version Date
April 01, 2022
Public Version Number
1
DI Record Publish Date
March 24, 2022
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 |