Duns Number:688817949
Device Description: Reusable Wrap (Ankle 1ea , Knee 1ea , Shoulder 1ea , Elbow 1ea , Back 1ea , Universal(M) 1 Reusable Wrap (Ankle 1ea , Knee 1ea , Shoulder 1ea , Elbow 1ea , Back 1ea , Universal(M) 1ea, Universal(L) 1ea)
Catalog Number
-
Brand Name
CTC-7
Version/Model Number
CTCSET-RT
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
-
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
8fc3f1c9-8b79-4808-a1d0-55bfd9be8dbd
Public Version Date
May 17, 2022
Public Version Number
1
DI Record Publish Date
May 09, 2022
Package DI Number
18809802643250
Quantity per Package
2
Contains DI Package
08809802643253
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |