Duns Number:108631797
Device Description: The LightMat Surgical Illuminator product family are supplied as sterile or non-sterile, s The LightMat Surgical Illuminator product family are supplied as sterile or non-sterile, single use, latex free, plastic fiber optic devices intended to bring cool area lighting into deep surgical sites. The LightMat is typically attached to various surgical retractors though use of adhesive strips and/or pre-applied adhesive backing. Some models of the LightMat also contain internal malleable members to provide moderate blunt retraction on its own.
Catalog Number
48250215
Brand Name
Fiber Optic Cable
Version/Model Number
005776
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDG
Product Code Name
Retractor, Fiberoptic
Public Device Record Key
44e5763e-37b2-4aaa-8fe4-8f2d537a770a
Public Version Date
February 04, 2019
Public Version Number
1
DI Record Publish Date
January 04, 2019
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 | 120 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |