Duns Number:080935429
Device Description: Snap Cap for 13 mm Tubes,Lavender
Catalog Number
1270019505
Brand Name
Monoject
Version/Model Number
1270019505
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
LXG
Product Code Name
EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
Public Device Record Key
c46aa0b5-ca31-4c22-9a7e-9dda7e9fd10d
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 29, 2018
Package DI Number
10884521073678
Quantity per Package
10000
Contains DI Package
20884521073675
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |