FDA.reportPublic FDA data

Dexter Monopolar Scissors

Primary DI
07640184840486
Brand
Dexter Monopolar Scissors
Company
Distalmotion SA
Model
Dexter L6
Catalog number
707
Device description
Dexter L6 Monopolar Scissors
Published
2024-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile FieldGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230084000Dexter L6 SystemDistalmotion SA2024-10-25SDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640184840486PackageGS14In Commercial Distribution
07640184840479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640184840486076401848404867640184840486
07640184840479076401848404797640184840479

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical arm systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-744-2602support@distalmotion.com

Regulatory Flags#

DUNS number
486345080
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
07640184840134Dexter L6 Accessory trayDexter L61472024-11-24
07640184840172Dexter L6 Incision PointerDexter L64132024-11-24
07640184840196Dexter L6 Emergency Release ToolDexter L64872024-11-24
07640184840219Dexter L6 Endoscope CartDexter L63392024-11-24
07640184840233Dexter Sterile InterfaceDexter L61402024-11-24
07640184840158Dexter L6 Handle GripDexter L61462024-11-24
07640184840516Dexter L6 RobotDexter L67102024-11-24
07640184840417Dexter Bipolar Maryland DissectorDexter L67012024-11-24
07640184840431Dexter Bipolar Johann GrasperDexter L67032024-11-24
07640184840455Dexter Needle HolderDexter L67052024-11-24
07640184840479Dexter Monopolar ScissorsDexter L67072024-11-24
07640184840493Dexter Monopolar Hook Dexter L67092024-11-24
07640184840547Dexter Bipolar Maryland DissectorDexter L65122025-10-07
07640184840608Dexter Monopolar ScissorsDexter L65182025-10-07
07640184840622Dexter Monopolar HookDexter L65202025-10-07
07640184840646Dexter Needle HolderDexter L65162025-10-07
07640184840660Dexter Bipolar Johann GrasperDexter L65142025-10-07
07640184840554Dexter Bipolar Maryland DissectorDexter L65122025-10-07
07640184840615Dexter Monopolar ScissorsDexter L65182025-10-07
07640184840639Dexter Monopolar HookDexter L65202025-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640184840547Dexter Bipolar Maryland DissectorDistalmotion SASDD2025-10-07
07640184840608Dexter Monopolar ScissorsDistalmotion SASDD2025-10-07
07640184840622Dexter Monopolar HookDistalmotion SASDD2025-10-07
07640184840646Dexter Needle HolderDistalmotion SASDD2025-10-07
07640184840660Dexter Bipolar Johann GrasperDistalmotion SASDD2025-10-07
07640184840554Dexter Bipolar Maryland DissectorDistalmotion SASDD2025-10-07
07640184840615Dexter Monopolar ScissorsDistalmotion SASDD2025-10-07
07640184840639Dexter Monopolar HookDistalmotion SASDD2025-10-07
07640184840653Dexter Needle HolderDistalmotion SASDD2025-10-07
07640184840677Dexter Bipolar Johann GrasperDistalmotion SASDD2025-10-07
07640184840684Dexter L6 RobotDistalmotion SASDD2025-10-07
07640184840134Dexter L6 Accessory trayDistalmotion SASDD2024-11-24
07640184840172Dexter L6 Incision PointerDistalmotion SASDD2024-11-24
07640184840196Dexter L6 Emergency Release ToolDistalmotion SASDD2024-11-24
07640184840219Dexter L6 Endoscope CartDistalmotion SASDD2024-11-24
07640184840233Dexter Sterile InterfaceDistalmotion SASDD2024-11-24
07640184840417Dexter Bipolar Maryland DissectorDistalmotion SASDD2024-11-24
07640184840431Dexter Bipolar Johann GrasperDistalmotion SASDD2024-11-24
07640184840455Dexter Needle HolderDistalmotion SASDD2024-11-24
07640184840479Dexter Monopolar ScissorsDistalmotion SASDD2024-11-24
07640184840493Dexter Monopolar HookDistalmotion SASDD2024-11-24
07640184840141Dexter L6 Accessory trayDistalmotion SASDD2024-11-24
07640184840158Dexter L6 Handle GripDistalmotion SASDD2024-11-24
07640184840189Dexter L6 Incision PointerDistalmotion SASDD2024-11-24
07640184840400Dexter L6 Emergency Release ToolDistalmotion SASDD2024-11-24
07640184840226Dexter L6 Endoscope CartDistalmotion SASDD2024-11-24
07640184840240Dexter Sterile InterfaceDistalmotion SASDD2024-11-24
07640184840424Dexter Bipolar Maryland DissectorDistalmotion SASDD2024-11-24
07640184840448Dexter Bipolar Johann GrasperDistalmotion SASDD2024-11-24
07640184840462Dexter Needle HolderDistalmotion SASDD2024-11-24