AccessGUDID - DEVICE: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (04953170310386)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
Version or Model: OLYMPUS LTF-S190-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170310386
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Rigid video laparoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted into the body through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the organs. This reusable device is used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, and ovarian cysts.

GMDN Preferred Term Name

GMDN Definition

Rigid video laparoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted into the body through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the organs. This reusable device is used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, and ovarian cysts.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: 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

Public Device Record Key: 4959e1b1-c520-485d-ba6f-f08c1d1f808f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016