Duns Number:338493631
Device Description: (8 Gal SHARPS USA RED Disposable Container w/Flat/Mono Lid) Single EA
Catalog Number
-
Brand Name
APmedical
Version/Model Number
FGAP30MRS001 AP30MR
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"
-
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
K071517
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
f26a2d7b-f012-4b2a-b376-4ad3eb08efd6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 92 |