Duns Number:037304144
Device Description: Fhc Head Section Pad (Pressure Relief). This Pad Incorporates A Layer Of Pressure Relief Fhc Head Section Pad (Pressure Relief). This Pad Incorporates A Layer Of Pressure Relief Viscoelastic Foam (A.K.A. Memory Foam) To Aid In The Prevention Of Pressure Ulcers During Longer Procedures The Balance Of The Foam Is High-Density Polyurethane Foam The Top Cover Material Is The Soft Stretchable Urethane-Coated Conductive Material With A Conductive Vinyl Sheeting Bottom Cover. (With Velcro Kit)
Catalog Number
BBFHC1000-H
Brand Name
Pad FHC Head Section Pad (Pressure Relief)
Version/Model Number
BBFHC1000-H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LWG
Product Code Name
Surgical Table Cushion
Public Device Record Key
8dd455f8-8654-4d22-a71d-1ab77eae5e89
Public Version Date
September 24, 2020
Public Version Number
1
DI Record Publish Date
September 16, 2020
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 | 287 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |