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.
04953170310386
GS1

1
711789789 *Terms of Use
LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE
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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
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111425 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4959e1b1-c520-485d-ba6f-f08c1d1f808f
April 22, 2024
6
September 21, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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