Duns Number:081277700
Device Description: Short Bulbous Tip for Metal Ear Syringes (REF # V919-381, V919-383, and V919-385)
Catalog Number
V919-390
Brand Name
Integra® Miltex®
Version/Model Number
V919-390
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
KCP
Product Code Name
SYRINGE, ENT
Public Device Record Key
4ee39dc0-dba8-4490-b54a-af94591d1de8
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
July 27, 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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |