Large Universal Spine Procedure Pack

EUDAMED

Class IIb (EU MDR)

Ref 42001673+

Identity

Primary DI / UDI-DI: 08592323031356 EUDAMED
Basic UDI-DI: 8592323PANEPACK9A EUDAMED
EMDN Code: T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED

Device Class: Class IIb EUDAMED
Medical Purpose: A procedure pack consisting of medical devices and other accessories intended, following sterilization, for the safe performance of both minor outpatient procedures and complex surgical interventions. The packs represent a comprehensive system and, owing to their optimized composition, provide maximum clinical utility. They contain components intended for draping and protecting the surgical field, equipment, healthcare personnel, and the patient, as well as products for preoperative skin disinfection, drying of the surgical wound, subsequent wound dressing, and other items specified by the end user to ensure the safe performance of the surgical procedure. The procedure packs are intended for single use only and are supplied sterile. Instructions for use are provided with each pack. The most critical component included in the pack is classified as a Class IIb medical device. EUDAMED

Sterile

Yes

EUDAMED

Large Universal Spine Procedure Pack by PANEP s.r.o. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	8592323PANEPACK9A	Class IIb	Active

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