Duns Number:081253414
Device Description: FLEX FRAME. Includes: 33528 - FLEX FRAME PATIENT PADS (10810050244203), 33529 - FLEX FRAME FLEX FRAME. Includes: 33528 - FLEX FRAME PATIENT PADS (10810050244203), 33529 - FLEX FRAME SECUREMENT STRAP SET (00810050244268), 33531 - FLEX FRAME CRANK HANDLE (00810050244275)
Catalog Number
-
Brand Name
NA
Version/Model Number
33516
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
GDC
Product Code Name
Table, Operating-Room, Electrical
Public Device Record Key
418fcebb-ea54-4282-b29c-9031ba988faf
Public Version Date
May 14, 2021
Public Version Number
1
DI Record Publish Date
May 06, 2021
Package DI Number
00810050244299
Quantity per Package
1
Contains DI Package
00810050244282
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 512 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |