Duns Number:001292192
Device Description: CAP TIP SYR LL/LS STER LF BLACK 10/TRAY
Catalog Number
308341
Brand Name
N/A
Version/Model Number
308341
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
f435b1c3-c0b6-45c2-9375-7393236145d2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
50382903083416
Quantity per Package
200
Contains DI Package
30382903083412
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 | 611 |
2 | A medical device with a moderate to high risk that requires special controls. | 614 |
3 | A medical device with high risk that requires premarket approval | 36 |
U | Unclassified | 4 |