Duns Number:965879187
Device Description: Individually Labeled: Waffle Grip Trendelenburg Positioning System, a Hot Dog Patient Warm Individually Labeled: Waffle Grip Trendelenburg Positioning System, a Hot Dog Patient Warming Accessory A300Box Labeled: Hot Dog Trendelenburg Positioning Kit Qty 10
Catalog Number
A300
Brand Name
Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming Accessory
Version/Model Number
A300
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"
Yes
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
K092807,K092807
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
78074608-412d-4ae1-a677-f26110d28268
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 28, 2016
Package DI Number
30855913001979
Quantity per Package
10
Contains DI Package
00855913001978
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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 |