Duns Number:008018525
Device Description: SILICONE I/A TIP STRAIGHT
Catalog Number
-
Brand Name
ALCON
Version/Model Number
8065740970
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
NKK
Product Code Name
NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED
Public Device Record Key
53b161ac-8f47-4f04-a304-f34fd23daf54
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
June 08, 2017
Package DI Number
10380657409706
Quantity per Package
4
Contains DI Package
00380657409709
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |