Duns Number:078505297
Device Description: The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coap The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket.
Catalog Number
-
Brand Name
Coapt Evaluation Kit
Version/Model Number
1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQO
Product Code Name
Device, Prosthesis Alignment
Public Device Record Key
34785ef6-f6ed-47e0-9a13-754e1540398c
Public Version Date
November 26, 2019
Public Version Number
1
DI Record Publish Date
November 18, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |