Aptos

Device name

Aptos Threads - Non Absorbable Surgical Sutures

Model / reference

Sole Otoplasty N, AN4.0030

Primary DI / UDI-DI

4860120240115

Basic UDI-DI

B-4860120240115

EMDN code

H010201010401 Polypropylene monofilament with needle for open surgery

Device class

Class IIb

System or procedure pack

Procedure pack which is a device in itself

EU registration type

Legacy device (under a directive)

EU market of registration

Czechia

EUDAMED SRN

GE-MF-000020012

Authorised representative

MDSS GmbH DE-AR-000005430

Other devices filed under POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

• Polypropylene 96843 by Assut Medical Sàrl
• Polypropylene 98753N by Assut Medical Sàrl
• Prolus TI/C-BRO/01 by TI Medical Private Limited
• Onatec OE471681 by Surgical Specialties México, S. de R.L. de C.V.
• Quill PPN JA-2007Q by Surgical Specialties México, S. de R.L. de C.V.
• DemeLENE PM194015F17P by DemeTECH Corp
• DemeLENE PM192026F4P by DemeTECH Corp
• TRULENE 8G70DZ17DA-12 by HEALTHIUM MEDTECH LIMITED
• P33263-45 by Foosin Medical Supplies Inc., Ltd.
• POLYPROPYLENE JE02M50 by GMD GROUP MEDİKAL SANAYİ VE TİCARET ANONİM ŞİRKETİ

• Aptos

  Class III

  CE/MDD

• Aptos Needle 2G Soft Large

  Class II

  FDA 510(k) K192953 Active Cleared 27 Aug 2020 GUDID on market

• Aptos Thread 2G

  Class II

  FDA 510(k) K192953 Active Cleared 27 Aug 2020 GUDID on market

• APTOS Threads Polypropylene Surgical Sutures

  Class II

  CE/MDD FDA 510(k) K192953 Active Cleared 27 Aug 2020

See all devices from Aptos, LLC →