Duns Number:047644935
Device Description: Rail Segment Extended Table Clamp, 6" Rail, Clamp length 3.86" (9.8cm), opening 2.23" (5.7 Rail Segment Extended Table Clamp, 6" Rail, Clamp length 3.86" (9.8cm), opening 2.23" (5.7cm)
Catalog Number
-
Brand Name
Flexarm Surgical Holders and Positioners
Version/Model Number
38113
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
53133dfb-e7a4-47a3-bce4-862660667af5
Public Version Date
November 05, 2021
Public Version Number
1
DI Record Publish Date
October 28, 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 | 882 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |