Duns Number:314546664
Device Description: BodyFIX® Cover Sheet HIP PLUS 2200x1400mm with sleeve includes five cover sheets. The cove BodyFIX® Cover Sheet HIP PLUS 2200x1400mm with sleeve includes five cover sheets. The cover sheets are placed over the patient to generate the vacuum. This set is used for the BodyFIX 14 BlueBAG HIP and Total Body.
Catalog Number
P10102-301
Brand Name
BodyFIX
Version/Model Number
P10102-301
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
Yes
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
K121530,K121530
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
f18edb47-83f0-41c4-8bf9-1d6bca8b4e87
Public Version Date
October 12, 2021
Public Version Number
3
DI Record Publish Date
August 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |