Duns Number:040876183
Device Description: TrenGuard 600 CLASSIC Packs - Each 4-piece Pack contains: "Speed Bump" Bolster, Head Stabi TrenGuard 600 CLASSIC Packs - Each 4-piece Pack contains: "Speed Bump" Bolster, Head Stabilizing Pillow, and 2 Lateral Stabilizing Pillows. Weight limit up to 250 kg. Case of 12 ea. 00811836030174 (model #56203)
Catalog Number
-
Brand Name
TrenGuard™
Version/Model Number
56101
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)
-
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
a4c4dcf4-b439-4c8c-9dfa-218a3a78d21c
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
May 17, 2021
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 | 28 |