FDA.reportPublic FDA data

SMTP

Primary DI
06972603519026
Brand
SMTP
Company
SMTP Medical Co., Ltd.
Model
XDF01838
Device description
Handpiece
Published
2023-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
JDXInstrument, Surgical, Sonic And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201274000Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.2021-02-19JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972603519026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972603519026069726035190266972603519026

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical system handpieceA hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current into an ultrasonic oscillation, and transfer the energy to an attachable tip, to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. The handpiece typically includes cables for power supply and tubing to circulate cooling fluid to the attachable tip. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
554428394
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972603519682SMTPXDF02806510C2026-06-08
06972603519675SMTPXDF028015212026-05-25
06972603519651SMTPXDF02806510C2026-04-01
06972603519668SMTPXDF02806510C2026-04-01
06972603519118SMTPXDF02806510C2023-08-15
06972603519125SMTPXDF02806510C2023-08-15
06972603519132SMTPXDF028065252023-08-15
06972603519149SMTPXDF028065252023-08-15
06972603519156SMTPXDF028125322023-08-15
06972603519170SMTPXDF028065182023-08-15
06972603519187SMTPXDF028065182023-08-15
06972603515769SMTPXDF028015202025-11-03
06972603519354SMTPXDF028015212024-12-16
06972603518791SMTPXDF028015212025-09-22
06972603518807SMTPXDF028015212025-09-22
06972603518517SMTPXDF028125322025-07-22
06972603519996SMTPXDF028065182025-07-22
06972603519361SMTPXDF028015212024-12-23
06972603519224SMTPXDF028065232024-06-21
06972603519231SMTPXDF028065232024-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972603519682SMTPSMTP Medical Co., Ltd.JDX2026-06-08
E322036000220MECTRONMECTRON SPAJDX2026-04-20
E322036300090MECTRONMECTRON SPAJDX2026-04-20
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030011Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030021Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030111Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030201Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030211Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030221Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030231Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHJDX2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHJDX2025-07-08