Duns Number:084527241
Device Description: General surgical table pad, Made with Tempur-Pedic® Medical materials.
Catalog Number
CT-356169011F
Brand Name
PAD, 2" FOOT, BERCHTOLD D850
Version/Model Number
CT-356169011F
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
-
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
FQO
Product Code Name
Table, Operating-Room, Ac-Powered
Public Device Record Key
450b044d-f565-4d8c-a86f-8350e5cbf4e5
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
June 30, 2017
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 | 1076 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |