Duns Number:361092450
Device Description: RELIEVA LUMA LIGHT GUIDE CABLE ADAPTER - OLYMPUS
Catalog Number
SISLGCAOLYMP
Brand Name
RELIEVA LUMA
Version/Model Number
SISLGCAOLYMP
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
-
Product Code
EQH
Product Code Name
SOURCE, CARRIER, FIBEROPTIC LIGHT
Public Device Record Key
f5a6ede1-dbfa-462b-b08f-fc876297ffd4
Public Version Date
January 22, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2017
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 | 83 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |