42010300

Organization name

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Manufacturer status

Active

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

• CW007

  Do not use the product if single dose container is damaged.
• CW032

  Do not use the eye drops beyond the expiry date which you can find on each single dose container and on the folding box.
• CW010

  Consult instructions for use.
• CW036

  Contact lenses have to be removed. If other eye preparations are to be applied, please consult your ophthalmologist. An interval of at least 15 minutes should be maintained between the two applications / before inserting the contact lenses.
• CW135

  Sodium Chloride 5% Eye Drops are in small plastic containers which could be swallowed by small children. Please keep the product out of the reach of children
• CW137

  Do not use in infected eyes.
• CW008

  Do not touch the eye with the single dose container.
• CW129

  Do not use if you are allergic to any of the ingredients.
• CW304

  Directly after application, a burning sensation and/or irritation of the affected eye may occur.
• CW011

  Temporary blurring for a brief period may be experienced after application; avoid driving, operating machinery and wait until normal vision is restored.
• CW277

  In case a serious incident has occurred during the use of this medical device or as a result of its use, please report it to the manufacturer and the competent authority.
• CW030

  Do not use without medical recommendation!

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

14260595530396

Basic UDI-DI

426059553MP12UD01JG

Reference / catalog number

42010300

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Sodium Chloride 5% Eye Drops (single dose container, 0.5ml) are used for treatment of corneal edema and removes due to its physical-osmotic properties the excess liquid and thus improves vision.

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.

• Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - OTHER