Duns Number:054386458
Device Description: 12mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded C 12mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, Amber Color, Size Large
Catalog Number
-
Brand Name
AmbiCanner
Version/Model Number
470-9-AM
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
LYY
Product Code Name
Latex patient examination glove
Public Device Record Key
ebf9fedf-279c-4f7c-a611-5f4b6b63aa6b
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
August 01, 2020
Package DI Number
10854947005942
Quantity per Package
24
Contains DI Package
00854947005945
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 | 12 |