Duns Number:542997182
Device Description: SHARPS CONTAINER, MULTIPLE TYPES
Catalog Number
-
Brand Name
NA
Version/Model Number
T1C
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101567,K101567
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
be540303-5f22-432a-ace4-2be69096b5c3
Public Version Date
April 16, 2021
Public Version Number
1
DI Record Publish Date
April 08, 2021
Package DI Number
16973696790016
Quantity per Package
100
Contains DI Package
06973696790019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |