Duns Number:007941230
Device Description: Pad Heat Therapy Neck Polyurethane 4 X 19 Inch Single Patient Use Not Made With Natural Ru Pad Heat Therapy Neck Polyurethane 4 X 19 Inch Single Patient Use Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
HTP003
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
Yes
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
ILO
Product Code Name
Pack, hot or cold, water circulating
Public Device Record Key
76a8b057-fcba-456f-86b2-61e1e075a074
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 20, 2016
Package DI Number
50885632112650
Quantity per Package
20
Contains DI Package
10885632112652
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |