Duns Number:616182895
Device Description: Non-Telescopic PenEvac®, Non-Stick ENT Needle, 10 Foot Tube, Universal Connector & Holster Non-Telescopic PenEvac®, Non-Stick ENT Needle, 10 Foot Tube, Universal Connector & Holster, Sterile
Catalog Number
ICM-000-0680
Brand Name
Non-Telescopic PenEvac
Version/Model Number
ICM-000-0680
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
67d21e91-c224-4e61-bc39-9ed1c9dd0e5b
Public Version Date
May 19, 2022
Public Version Number
1
DI Record Publish Date
May 11, 2022
Package DI Number
00817688023913
Quantity per Package
20
Contains DI Package
00817688023906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 180 |