Duns Number:961027315
Device Description: 10 mL Oral Syringe Clear
Catalog Number
8881907102
Brand Name
Monoject
Version/Model Number
8881907102
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
-
Product Code
KYW
Product Code Name
CONTAINER, LIQUID MEDICATION, GRADUATED
Public Device Record Key
e40a9c0e-c484-4e7c-b9a2-d25fd1aa3635
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 20, 2022
Package DI Number
50192253038710
Quantity per Package
5
Contains DI Package
20192253038719
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |