Duns Number:316153824
Device Description: Berchtold Surgical Table, D 752
Catalog Number
OT 1812104
Brand Name
Operon
Version/Model Number
OT 1812104
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 13, 2022
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
GDC
Product Code Name
TABLE, OPERATING-ROOM, ELECTRICAL
Public Device Record Key
9c6977b6-7bd7-49e2-944a-4d6eddfd4f70
Public Version Date
October 17, 2022
Public Version Number
2
DI Record Publish Date
August 21, 2019
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 | 102 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |