Duns Number:002397347
Device Description: Tamper Evident Syringe Cap - Red
Catalog Number
418004
Brand Name
Tamper Evident Cap
Version/Model Number
418004
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"
Yes
For Single-Use
Yes
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
0b1b6e8b-146c-47d9-8d49-70c887ced8f8
Public Version Date
October 07, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
04022495825377
Quantity per Package
50
Contains DI Package
04046963579678
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 277 |
U | Unclassified | 2 |