Duns Number:965879187
Device Description: WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for Warming Pa WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for Warming Pad
Catalog Number
A330
Brand Name
WaffleGrip PadLock Bracket Set
Version/Model Number
A330
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
bfb57c91-010b-490c-b54e-0815f46a9374
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |