Duns Number:947090650
Device Description: Carbon Fiber Trendelenburg restraint table accessory. Designed for preventing patient move Carbon Fiber Trendelenburg restraint table accessory. Designed for preventing patient movement while using the Trendelenburg position for surgical procedures. Device is attached to the operating table's side rails via accessory clamps.
Catalog Number
-
Brand Name
Trenstop
Version/Model Number
1-1002-001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
51e88f67-680c-4477-ab0d-ca929ef620e1
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
February 13, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |