Cutegel Lidocaine
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Basic Information
- Primary DI
- 08809369092860
- Basic UDI-DI Code
- B-08809369092860
- Reference
- LLN
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- BNC KOREA, Inc.
Additional Description
This product consists of stabilized sodium hyaluronate generated by streptococcal bacteria and formulated to a concentration of 20 mg/mL, suspended in a physiological buffer. It is a transparent, viscous and sterile gel, supplied in a disposable pre-filled syringe. The syringe is equipped with a plunger, a plunger rod and a finger grip. It has one syringe and two needles in a blister pack. The product contains Lidocaine hydrochloride (3.0 mg/ 1mL) and the addition of lidocaine provides a pain relieving effect during treatment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2021-MDD/QS-023, 2021-MDD/DE-024 | 3EC International a.s. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).