FDA.reportPublic FDA data

Taiwan Surgical

Primary DI
04717480900428
Brand
Taiwan Surgical
Company
TAIWAN SURGICAL CORPORATION
Model
TSI-545
Device description
5mm x 45cm Stainless Steel probe, 290cm Soft Tube
Published
2023-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150253000Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mmTaiwan Surgical Corporation2015-04-01GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04717480900428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04717480900428047174809004284717480900428

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (typically laparoscopy), usually to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657134172
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
04717480900336Inno-PortDT501-7A2026-06-08
04717480900343Inno-PortDT501-7E2026-06-08
04717480900350Inno-PortDT501-XA2026-06-08
04717480900367Inno-PortDT501-XE2026-06-08
04717480900398Inno-PortDTW01-XA2026-06-08
04717480900404Inno-PortDTW01-XE2026-06-08
04717480900763Inno-PortDTY01-XA2026-06-08
04717480900770Inno-PortDTY01-XE2026-06-08
04717480900787Inno-PortDTY01-SA2026-06-08
04717480900800Inno-PortDTY01-SE2026-06-08
04717480902064InnoClipTRC-TM1212026-06-05
04717480902101InnoClipTRC-TL1212026-06-05
04717480902118InnoClipRC003-002026-06-05
04717480902149InnoClipTRC-TM1112026-06-05
04717480902170InnoClipTRC-TL1112026-06-05
04717480902217InnoClipDCXT1-LX2026-06-05
04717480902293InnoClipDCXT1-BX2026-06-05
04717480902347InnoClipRC5T1-B62023-07-11
04717480902354InnoClipRC5T1-BX2023-07-11
14717480902016InnoClipTDC-10-ML2023-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18