SCANLAN® Minimally Invasive Instrumentation

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 9009-562

by Scanlan International Inc

Identity

Trade Name: SCANLAN® Minimally Invasive Instrumentation FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: SCANLAN® Thoracoscopic Axial Needle Holder EUDAMED
Thoracoscopic Axial Needle Holder, (7mm), (for 4-0 and smaller needles), gold-tipped round handle, axial design, curved carbon-inlay jaws, without ratchet, 20 cm working length, 14-3/8”/36.5 cm total length FDA UDI
Model / Reference: 9009-562 EUDAMEDFDA UDI
Description: Thoracoscopic Axial Needle Holder, (7mm), (for 4-0 and smaller needles), gold-tipped round handle, axial design, curved carbon-inlay jaws, without ratchet, 20 cm working length, 14-3/8”/36.5 cm total length FDA UDI

Identifiers

Catalog Number: 9009-562 FDA UDI
Primary DI / UDI-DI: 00846159024258 EUDAMEDFDA UDI
Basic UDI-DI: B-00846159024258 EUDAMED
510(k) Number: K945474 FDA UDI
FDA Product Code: GCJ FDA UDI
EMDN Code: L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
GMDN Term: Suturing needle holder, 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: Suturing needle holder, reusable

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

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Also classified as Suturing needle holder, reusable.

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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

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Manufacturer

Manufacturer: Scanlan International Inc

Sources (2)

FDA UDI 768abb9d-d7f0-4f6f-80f3-0b5be5005992 36 fields · synced Jul 24, 2026
EUDAMED 8535542b-1f5a-457c-a1e3-1679868c74cd 61 fields · synced Jul 24, 2026