AccessGUDID - DEVICE: LiNA OperaScope™ with HDMI cable (05708265013388)

GUDID

Device Identifier (DI) Information

Brand Name: LiNA OperaScope™ with HDMI cable
Version or Model: OP-200-6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lina Medical ApS

Primary DI Number: 05708265013388
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305088619 *Terms of Use

Device Description: LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hysteroscopy and cystoscopy

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:	Yes
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63256	Rigid video hysteroscope	An electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	Hysteroscope (And Accessories)
FAJ	Cystoscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 9259ce0b-195e-4bdb-b196-9b7398b67ce7
Public Version Date: December 13, 2021
Public Version Number: 1
DI Record Publish Date: December 03, 2021