FDA.reportPublic FDA data

SCANLAN® Scanturian®

Primary DI
00846159036145
Brand
SCANLAN® Scanturian®
Company
SCANLAN INTERNATIONAL INC
Model
9019-470-25
Catalog number
9019-470-25
Device description
SCANTURIAN® MIS FORCEPS
Published
2025-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945474000SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERScanlan Intl., Inc.1994-12-05GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159036145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159036145008461590361458461590361450846159036145

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159036411SCANLAN® Clamp3785-443785-442026-09-21
00846159036428SCANLAN® Clamp3786-443786-442026-09-21
00846159040845SCANLAN® ScissorsQ32034Q320342026-08-26
00846159040852SCANLAN® ScissorsQ32035Q320352026-08-26
00846159040869SCANLAN® ScissorsQ32046Q320462026-08-26
00846159040678SCANLAN® Minimally-Invasive InstrumentationQ29142-9Q29142-92026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationQ29150-9Q29150-92026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationQ29163-9Q29163-92026-07-17
00846159040708SCANLAN®9009-941P9009-941P2026-07-17
00846159036152SCANLAN® Bulldog Clamp3795-453795-452026-06-23
00846159036404SCANLAN® Bulldog Clamp3795-553795-552026-06-09
00846159040524SCANLAN® Retractor8008-568008-562026-06-04
00846159040531SCANLAN® Retractor8008-598008-592026-06-04
00846159040548SCANLAN® Retractor8008-608008-602026-06-04
00846159040555SCANLAN® Retractor8888-058888-052026-06-04
00846159040562SCANLAN® Retractor8888-588888-582026-06-04
00846159040579SCANLAN® Retractor8989-188989-182026-06-04
00846159040586SCANLAN® RetractorQ195Q1952026-06-04
00846159040593SCANLAN® RetractorQ219Q2192026-06-04
00846159040609SCANLAN® RetractorQ222Q2222026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269555Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269562Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269579Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269593Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
04995047072416CuratOREIZO CORPORATIONGCJ2026-09-25
00190776432348MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432386MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432416MillenniumAvalign Technologies, Inc.GCJ2026-09-24