Idracare Vaginal Gel

Organization name

Procare Health Iberia SL

SRN

ES-MF-000001950

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW018

  If after application you experience discomfort, the use of the product should be discontinued, and the doctor consulted. No data are available on the use of Idracare® with vaginal contraceptives (e.g., vaginal ring, female condom) so, the use of Idracare® in women who are using this type of contraceptive is not recommended. Unopened, do not use after expiry date on the packaging, the gel may have degraded and not perform as intended. Once opened, the gel must be consumed in 6 weeks after first opening the tube. Do not use after. Ensure cleaning between use to prevent contamination. Do not share applicator due to risk of cross-infection. Do not use the applicator if the measuring line is not clearly marked on it. Do not use if packaging or seal is compromised or if the product is damaged. Store only at the temperatures stated to avoid degradation of the gel. Do not use the applicator if you detect cracks in the plastic, sharp burrs on the part to be inserted in the vagina, or if the part is incomplete. Applicator shelf-life is 4 years. The applicator has no contraindications and no known side effects. Use the applicator only with Idracare® vaginal gel and to measure only the amount indicated in this Instructions for Use (line marked at 2 ml). No overdose problems can be expected with the use of Idracare®. However, there are no studies conducted considering this situation and it is recommended to be used only under strict medical supervision.

Primary placement in Spain; available across 3 countries total.

Trade name

Idracare Vaginal Gel

UDI-DI code

08437018976430

Basic UDI-DI

B-08437018976430

Reference / catalog number

-

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Vaginal Gel

Additional information URL

https://www.procarehealth.com/

Clinical sizes

No clinical sizes registered for this device.

• U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

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