DEVICE: HD EndoEYE LAPARO-THORACO VIDEOSCOPE (04953170287015)
Device Identifier (DI) Information
HD EndoEYE LAPARO-THORACO VIDEOSCOPE
OLYMPUS LTF TYPE VH
Not in Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS LTF TYPE VH
Not in Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
LTF-VH ENDOEYE FLEX 10 HD 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
| GCJ | Laparoscope, general & plastic surgery |
| NWB | Endoscope, accessories, narrow band spectrum |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
No
Yes
CLOSE
Yes
| Sterilization Method [?] |
|---|
| High-level Disinfectant |
| Ethylene Oxide |
| Moist Heat or Steam Sterilization |
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
e2df5aff-36bf-4ee6-948c-851cfe280cea
January 15, 2024
5
September 21, 2016
January 15, 2024
5
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