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Organization name

i+Med S.Coop.

SRN

ES-MF-000008633

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW009

  SINGLE USE PRODUCT. The reuse of the product may lead to an infection since sterility is compromised after first use.
• CW001

  DO NOT RE-STERILISE, since re-sterilization may affect the physico-chemical properties of the product and compromise its efficacy and security.
• CW007

  The product should not be used if the package is damaged or broken.
• CW032

  The product should not be used after its expiration date.
• CW135

  KEEP OUT OF THE REACH OF CHILDREN.
• CW276

  Do not use with other products containing quaternary ammonium salts because sodium hyaluronate can precipitate in their presence.
• CW999

  Do not overfill the eye structures with the product, since it can cause increase in IOP or cause ocular damage. The quantity injected into the anterior chamber of the eye must be adjusted according to the volume of the aqueous humour and the anatomical structure to be protected. Monitor IOP increment especially during immediate postoperative period or in patients with pre-existing glaucoma. If significant rises are observed after surgery, appropriate treatment should be prescribed. To avoid increase of IOP, the product must be removed by irrigation and/oraspiration from the anterior chamber after surgery. Use only if the solution is clear. The product should be used with the provided cannula. The cannula and the syringe are for single intraocular use only and must be disposed after using the necessary precautions. Verify that the cannula is properly locked to the Luer-lock adaptor. Care should be taken to avoid trapping air bubbles behind the OVD. The normal precautions associated with ocular microsurgery should be observed. STRICT ASEPTIC PROCEDURE SHOULD BE FOLLOWED.

Primary placement in Spain; available across 3 countries total.

Trade name

not provided

UDI-DI code

08437015992761

Basic UDI-DI

B-08437015992761

Reference / catalog number

-

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1.2 MU48

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

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

• Q02030301OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES