Duns Number:985523874
Device Description: Latex Exam Glove Size: Extra Large
Catalog Number
-
Brand Name
Amerisource Bergen
Version/Model Number
10013
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2022
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)
Yes
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
ce1b44ef-9a0a-4101-99f4-e569a0c9561e
Public Version Date
September 07, 2022
Public Version Number
3
DI Record Publish Date
November 18, 2021
Package DI Number
60368001100139
Quantity per Package
10
Contains DI Package
00368001100137
Package Discontinue Date
June 30, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |