Duns Number:616182895
Device Description: ICM-000-0666 STERIS Telescopic ESU Pencil, Stainless Steel ENT Needle, 10 Foot Tube & Hols ICM-000-0666 STERIS Telescopic ESU Pencil, Stainless Steel ENT Needle, 10 Foot Tube & Holster, Sterile
Catalog Number
SSEPET13
Brand Name
STERIS
Version/Model Number
SSEPET13
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
019ab055-9318-43f1-9fb6-8713d14faeee
Public Version Date
May 19, 2022
Public Version Number
1
DI Record Publish Date
May 11, 2022
Package DI Number
00817688023777
Quantity per Package
20
Contains DI Package
00817688023760
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 |