Duns Number:063865158
Device Description: Protective Mitts - Double Essential Secure - No Finger Separators - Adult One Size - Pair
Catalog Number
MTRM289
Brand Name
Protective Mitts
Version/Model Number
MTRM289
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110377
Product Code
FMQ
Product Code Name
Restraint, Protective
Public Device Record Key
01937c45-7c17-4097-9e35-a4fd6407735c
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
July 23, 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 | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |