Duns Number:157308230
Device Description: The MICRO+ MR MLB+350 Laser is used for aligning patients to medical diagnostic imaging an The MICRO+ MR MLB+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
Catalog Number
808878
Brand Name
Sun Nuclear MICRO+ MR
Version/Model Number
MLB+350MR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
-
Product Code
IWE
Product Code Name
Monitor, Patient Position, Light-Beam
Public Device Record Key
4b18525c-5f31-4ff2-a3b6-2fee376a211c
Public Version Date
February 02, 2021
Public Version Number
1
DI Record Publish Date
January 25, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 72 |