Duns Number:196548481
Device Description: SafeAir Telescopic Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button, Non-Sterile
Catalog Number
0703-046-006
Brand Name
Stryker
Version/Model Number
0703-046-006
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"
-
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
520bfebf-636c-40d2-8112-3d87e2978583
Public Version Date
November 22, 2019
Public Version Number
2
DI Record Publish Date
October 16, 2019
Package DI Number
37613327465656
Quantity per Package
10
Contains DI Package
07613327465655
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |