SCANLAN® Minimally-Invasive Instrumentation

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 9009-843SC

by Scanlan International Inc

Identity

Trade Name: SCANLAN® Minimally-Invasive Instrumentation FDA UDI
Generic Name: Rigid endoscopic scissors, reusable FDA UDI
Device Name: SCANLAN® Thoracoscopic SUPER CUT™ Suture Cutter EUDAMED
SCANLAN® Chitwood Suture Cutter FDA UDI
Model / Reference: 9009-843SC EUDAMEDFDA UDI
Description: SCANLAN® Chitwood Suture Cutter FDA UDI

Identifiers

Catalog Number: 9009-843SC FDA UDI
Primary DI / UDI-DI: 00846159035537 EUDAMEDFDA UDI
Basic UDI-DI: B-00846159035537 EUDAMED
510(k) Number: K945474 FDA UDI
FDA Product Code: GCJ FDA UDI
EMDN Code: L01040402 VASCULAR SCISSORS, REUSABLE EUDAMED
GMDN Term: Rigid endoscopic scissors, reusable FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscopic scissors, reusable

SCANLAN® Minimally-Invasive Instrumentation by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Rigid endoscopic scissors, reusable.

Ambler Surgical — Ambler Surgical, LLC · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
ELMED — ELMED INCORPORATED · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Olympus — Olympus Winter & Ibe GmbH · Class II
ELMED — ELMED INCORPORATED · Class II

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Scanlan International Inc

Sources (2)

FDA UDI f28add6e-7024-4a42-83de-ec0273473052 36 fields · synced Jul 9, 2026
EUDAMED 59bcc029-8df7-413e-b1af-cf45d232a6ce 61 fields · synced Jul 9, 2026