Duns Number:007198742
Catalog Number
-
Brand Name
SHEATH, LENS CLEANER OLYMPUS 30°, BTM LIGHT InstaClear
Version/Model Number
LCS1530BTOL
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
Yes
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
K152531,K152531
Product Code
EOB
Product Code Name
NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
cdbcab64-ca72-492e-9b60-4905f44d71a4
Public Version Date
July 29, 2019
Public Version Number
6
DI Record Publish Date
October 05, 2016
Package DI Number
00821925039988
Quantity per Package
5
Contains DI Package
00821925040151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |