44007400L

Organization name

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Manufacturer status

Active

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

• CW007

  Do not use the product if the safety ring of the tamper evident closure is broken or the bottle 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 5 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
• CW008

  Do not touch the eye with the single dose container. Do not allow any contact between the opening of the unit dose container and other surfaces to avoid risk of contamination.
• CW304

  Directly after application, a burning sensation and/or irritation of the affected eye may occur.
• CW030

  Do not use without medical recommendation!

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260595531747

Basic UDI-DI

B-04260595531747

Reference / catalog number

44007400L

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC 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