Duns Number:007131725
Device Description: SYR 200ML 10MLGRV 2MLGRAD
Catalog Number
CR1914
Brand Name
CR1914 SYRINGE
Version/Model Number
CR1914
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BXW
Product Code Name
Calibrator, Volume, Gas
Public Device Record Key
d4f5321b-098b-450b-a250-eae91bdc54ab
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 08, 2018
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 | 
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 922 | 
| 2 | A medical device with a moderate to high risk that requires special controls. | 407 |