Duns Number:111267330
Device Description: MICRO-TOUCH Central Supply-SPD Plus ULNCS Size XXL, Nitrile Powder-Free Examination Glove
Catalog Number
ULNCS-5
Brand Name
MICRO-TOUCH
Version/Model Number
ULNCS-5
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
3c032009-c88b-4f13-9a8d-893ff2c845ba
Public Version Date
March 25, 2022
Public Version Number
1
DI Record Publish Date
March 17, 2022
Package DI Number
50741013081154
Quantity per Package
10
Contains DI Package
00741013081159
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |