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

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Primary DI, Brand, Company table
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00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18
10850013527936DANNIKDannik LLCGCJ2026-08-17
108500135279817mm XL SUPERBAGDannik LLCGCJ2026-08-17
00889095731972ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
00889095731989ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
00190776423605MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423650MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423667MillenniumAvalign Technologies, Inc.GCJ2026-08-07
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04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
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B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
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B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
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B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
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