DEVICE: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (04953170310386)
Device Identifier (DI) Information
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
OLYMPUS LTF-S190-10
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS LTF-S190-10
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
43053 | Rigid video laparoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FGB | Ureteroscope and accessories, flexible/rigid |
NWB | Endoscope, accessories, narrow band spectrum |
EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) |
GCJ | Laparoscope, general & plastic surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K111425 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Moist Heat or Steam Sterilization |
High-level Disinfectant |
Ethylene Oxide |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4959e1b1-c520-485d-ba6f-f08c1d1f808f
April 22, 2024
6
September 21, 2016
April 22, 2024
6
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx