Duns Number:004193103
Device Description: CRYSTAL HP CLASSIC LILAC PURPLE, TIPS
Catalog Number
CT1509
Brand Name
Crystal Tip
Version/Model Number
CT1509
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
-
Product Code
ECB
Product Code Name
UNIT, SYRINGE, AIR AND/OR WATER
Public Device Record Key
ec61d5f5-8173-4b3a-b010-7377c3e3457f
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 23, 2022
Package DI Number
10843471132682
Quantity per Package
250
Contains DI Package
00843471132685
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Package
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 77 |
2 | A medical device with a moderate to high risk that requires special controls. | 38 |