FDA.reportPublic FDA data

VECTR

Primary DI
00860010523919
Brand
VECTR
Company
Rafael Medical Devices, LLC
Model
5200-90
Device description
VECTR - Display VPU
Published
2025-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242417000VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC2024-12-11HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010523919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010523919008600105239198600105239190860010523919

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image display unitAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(973) 381-0411info@rafaelmedicaldevices.com

Regulatory Flags#

DUNS number
119025136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010523902VECTR5200-012025-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854041116POWERPROConmed CorporationHRX2026-03-24
04056702011970PUREVUE™ FMSW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011987Autoclavable remote controlW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011994Double pedal foot switchW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012014Tube set for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012038Tube set for suction, 2-lines, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012076Patient tube for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012113Tube set for suction, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012137Tube set inflow 4-Spike adaptorW.O.M. World of Medicine GmbHHRX2026-03-10
00763000956028Tubing SetMEDTRONIC XOMED, INC.HRX2026-02-14
B382SD401290Surgical DirectSurgical Direct, Inc.HRX2026-02-09
B382SD401490Surgical DirectSurgical Direct, Inc.HRX2026-02-09
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHRX2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHRX2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHRX2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHRX2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHRX2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHRX2025-12-17
06938695521026DrillShanghai Kinetic Medical Co., Ltd.HRX2025-12-09
08800038029323SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24