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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

33272 — Class I MDR by Produits Dentaires SA

MD Atlas
Produits Dentaires SA

EUDAMED last updated this device on May 24, 2023

33272

764015916COTTONPELLETS32

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Produits Dentaires SA
UDI-DI code: 07640159161417
Reference / catalog number: 33272

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Manufacturer information

Organization name: Produits Dentaires SA
SRN: CH-MF-000023147
Manufacturer status: Active

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Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 07640159161417
Basic UDI-DI: 764015916COTTONPELLETS32
Reference / catalog number: 33272
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Cotton Pellets are cotton fiber spun into round ball, used to dry/absorb or apply substances during dental procedures. PD Cotton pellets are highly absorbent and uniform in shape. The cotton used is a purified medical grade cotton with TCF (Total Chlorine Free) certification. The purification process is done with “oxygen purification” (through hydrogen peroxide), leading to a cotton without any trace of chlorine. The product is available in different diameters. The cotton pellets are packaged either in bulk (18g or 32g) or in refill (6x3g).
Additional information URL: https://pd-dental.com/products/cotton-pellets/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q019004DENTAL COTTON ROLLS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

Certificates

Certificate health across this manufacturer's portfolio.

CH24/00000115Issued
Quality management systemNotified body: 1639Expiry: Nov 28, 2029