Duns Number:071595540
Device Description: BEAMER ARGON SIDEFIRE PROBE, SIDEFIRE PROBE FOR FLEXIBLE ENDOSCOPY
Catalog Number
S-BEAM-3
Brand Name
BEAMER
Version/Model Number
S-BEAM-3
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
K081644,K081644,K081644
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
593deb22-040d-4380-b8ef-efd9f737de5b
Public Version Date
April 23, 2019
Public Version Number
1
DI Record Publish Date
April 15, 2019
Package DI Number
20653405986468
Quantity per Package
10
Contains DI Package
10653405986461
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |