FDA.reportPublic FDA data

SMTP

Primary DI
06972603519040
Brand
SMTP
Company
SMTP Medical Co., Ltd.
Model
XDF0980115
Device description
Liquid-flow sleeve (hard)
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
06972603519040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972603519040069726035190406972603519040

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system handpiece cooling sleeveA removable attachment to an ultrasonic surgical system handpiece intended to contain the flow of coolant liquid, supplied through the handpiece, over the ultrasonic surgical system handpiece tip; the coolant is intended to prevent overheating of the tip during a surgical procedure. It is typically a funnel-shaped sleeve designed to fit over the distal end of the handpiece and cover a portion of the 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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06972603519217SMTPXDF068012023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E322036000220MECTRONMECTRON SPAJDX2026-04-20
E322036300090MECTRONMECTRON SPAJDX2026-04-20
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