GMS 805

Organization name

LiNA Medical ApS

SRN

DK-MF-000003706

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW001

  For single use only. Do not reuse, reprocess or re-sterilize the LiNA Versascope™ Sheath. Any reprocessing may impede the functions of the device. Reusing single use devices may also increase the risk of cross contamination which may lead to infection or transmission of bloodborne pathogens to patients and users. Attempts to clean the device results in risk of device malfunction.
• CW007

  The LiNA Versascope™ Sheath is supplied sterile using an ethylene oxide. Carefully inspect the packaging for any damage prior to use. Do not attempt to use the device if product sterile barrier or its packaging is damaged
• CW009

  For single use only. Do not reuse, reprocess or re-sterilize the LiNA Versascope™ Sheath. Any reprocessing may impede the functions of the device. Reusing single use devices may also increase the risk of cross contamination which may lead to infection or transmission of bloodborne pathogens to patients and users. Attempts to clean the device results in risk of device malfunction.
• CW032

  Do not use past expiration date.
• CW011

  Hysteroscopy procedures performed during pregnancy can result in miscarriage. Suspicion of pregnancy should suggest a pregnancy test prior to the performance of diagnostic hysteroscopy.

Primary placement in Denmark; available across 7 countries total.

Trade name

not provided

UDI-DI code

05708265013531

Basic UDI-DI

57082651023-1ZH

Reference / catalog number

GMS 805

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The LiNA Versascope™ Sheath GMS805 is a curved access sheath of small diameter intended to be used only with the compatible hysteroscope AlphaScope Hysteroscope (GMS40A). The LiNA Versascope Sheath is a single use, sterile device comprised of both metal and plastic components. The device incorporates a channel for insufflation accessed through the attached tubing and connector. Also incorporated is an expandable channel for insertion of hysteroscopic instruments which provides continuous flow where fluids media is utilized for distention. A rational collar provides convenient viewing perspective of the uterine cavity.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12020799GENITOURINARY ENDOSCOPY INSTRUMENTS – OTHER

Certificate health across this manufacturer's portfolio.