FDA.reportPublic FDA data

SMTP

Primary DI
06972603518807
Brand
SMTP
Company
SMTP Medical Co., Ltd.
Model
XDF02801521
Device description
Bilateral scalpel with serrations (14cm)
Published
2025-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LFLInstrument, Ultrasonic Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212750000Ultrasonic Surgical Aspirator System, Model: XD880BSmtp Technology Co., Ltd.2021-09-27LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972603518807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972603518807069726035188076972603518807

GMDN Terms#

Term, Definition table
TermDefinition
Hard/soft-tissue ultrasonic surgical systemAn assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement during an orthopaedic surgical procedure (e.g., arthroplasty revision, 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. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554428394
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
06972603518517SMTPXDF028125322025-07-22
06972603519996SMTPXDF028065182025-07-22
06972603519361SMTPXDF028015212024-12-23
06972603519224SMTPXDF028065232024-06-21
06972603519231SMTPXDF028065232024-06-21
06972603519217SMTPXDF068012023-08-15
06972603519002SMTPXD880A2023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327586565N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
07613327586589N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
10705036035763HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10705036035770HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10705036035787HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10381780536383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-07-14
10381780533870CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
10381780533894CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
07613327576627Sonopet iQSTRYKER CORPORATIONLFL2023-03-24
10381780536369CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780536352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780533863CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-09-06
07613327548105Sonopet iQSTRYKER CORPORATIONLFL2021-06-14
10705036026167HarmonicETHICON ENDO-SURGERY, LLCLFL2020-12-18
10705036026174HarmonicETHICON ENDO-SURGERY, LLCLFL2020-12-11
10857156006076Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10857156006144Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10857156006205Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10884521807884SonicisionCovidien LPLFL2020-06-29
07613327298635Sonopet iQSTRYKER CORPORATIONLFL2019-05-10
10381780466215CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
10381780466383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
07613327422382Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422399Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422405Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422412Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422429Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422436Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422443Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422450Sonopet iQSTRYKER CORPORATIONLFL2019-05-02