Duns Number:109903521
Device Description: OLYMPUS SOURCE OS VERSITIP ADAPTOR. INTENDED TO INTERFA OLYMPUS SOURCE OS VERSITIP ADAPTOR. INTENDED TO INTERFACE SMITH and NEPHEW GEMINI UNIVERSAL FIBER OPTIC LIGHT CABLE WITH OLYMPUS LIGHT SOURCES.
Catalog Number
2145
Brand Name
VERSITIP
Version/Model Number
2145
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
K914919
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
593f496d-71f2-4db5-a295-6ae61facb189
Public Version Date
October 07, 2020
Public Version Number
5
DI Record Publish Date
August 30, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |