Duns Number:118269952
Device Description: EXTLI - Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Hol EXTLI - Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Catalog Number
-
Brand Name
MediSourceNet, Inc
Version/Model Number
EXTLI
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092732,K143103,K092732,K143103
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
2e76aaee-1570-4bbe-a02a-ad84d8fa2cc4
Public Version Date
September 07, 2021
Public Version Number
1
DI Record Publish Date
August 30, 2021
Package DI Number
10850034735099
Quantity per Package
20
Contains DI Package
00850034735092
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |