Organization name

Pfizer Manufacturing Belgium NV

SRN

BE-MF-000003721

Manufacturer status

Active

Primary placement in France; available across 12 countries total.

Trade name

Prepidil Gel Catheter

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

15415062394820

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

5415062PPU5N04734D

Reference / catalog number

H000037140 OTH-CATHETER BLISTER ST. PAA236038 UNIV

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The endocervical catheter (Sterile) is a medical device that was developed to facilitate the local administration of the endocervical gel, marketed under the name Prepidil Gel, and with Active Pharmaceutical Ingredient Dinoprostone. The medicinal product that is supplied and to be used with the catheter is filled in a plastic syringe. The Endocervical Catheter (Sterile) is used to administer the sterile gel into the neck of the cervix. It is intended to be a single-use device for transient use, as it will typically be in contact with the cervix less than one minute. The Endocervical Catheter (Sterile) is a one-piece device which is manufactured by injection molding Low Density Polyethylene (LDPE) and Ethylene Vinyl Acetate Copolymer (EVA). The Endocervical Catheter (Sterile) is to be integrated with the prefilled syringe containing sterile Prepidil Gel (Dinoprostone Endocervical Gel) by placing the catheter on top of the syringe. The catheter should click into place - which is clearly noticeable by a distinct audible click because of the designed snap ring – after which the combination is ready to operate. The sterile gel is dispensed into the cervix via the catheter. Since the catheter is used for administration of a sterile gel: Prepidil Gel (Dinoprostone Endocervical Gel), the catheter is produced and packed so that the bioburden is kept low, after which the device is terminally sterilized using gamma irradiation.

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.

• U080199GYNAECOLOGICAL CATHETERS - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.