Duns Number:007941230
Device Description: Mitts Finger Control With Mesh Back One Size Fits All Pair 5 Finger Separators Cotton Poly Mitts Finger Control With Mesh Back One Size Fits All Pair 5 Finger Separators Cotton Polyester And Polyester Fiberfill Hook And Loop Wrist Closure Optional 48.5 Inch Strap Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
MTT2816
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110377,K110377
Product Code
FMQ
Product Code Name
Restraint, protective
Public Device Record Key
88623e92-f107-4ccf-abe9-30dbd53e4b28
Public Version Date
October 20, 2020
Public Version Number
1
DI Record Publish Date
October 12, 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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |