Duns Number:185444825
Device Description: ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
Catalog Number
252510EC
Brand Name
ZIP Pen
Version/Model Number
252510EC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141587,K141587
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
db721598-c5a0-45c3-a772-3e96b38af456
Public Version Date
June 11, 2021
Public Version Number
5
DI Record Publish Date
September 04, 2018
Package DI Number
30614559105348
Quantity per Package
20
Contains DI Package
10614559105344
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |