Duns Number:332247852
Device Description: Surgical laser with 2 laser modules of 1940 nm and 1470 nm (both near infrared). Intended Surgical laser with 2 laser modules of 1940 nm and 1470 nm (both near infrared). Intended for surgical procedures using open, laparoscopic and endoscopic procedures of soft tissue in many medical specialties.
Catalog Number
-
Brand Name
MultiPulse TM+1470
Version/Model Number
1901
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
-
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
K133891
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
468305ed-979f-4a42-ae09-300351701101
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |