Duns Number:080458964
Device Description: Non-Sterile Heel/Elbow Protection Cushion
Catalog Number
75658-00003-00
Brand Name
Spectrum, Inc.
Version/Model Number
985-03938-000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
KIC
Product Code Name
CUSHION, FLOTATION
Public Device Record Key
e51e3878-25ee-42d1-a408-07e258f05700
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 21, 2017
Package DI Number
10855495007402
Quantity per Package
2
Contains DI Package
00855495007405
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| U | Unclassified | 11 |