Taiwan Surgical

Primary DI
04717480900435
Brand
Taiwan Surgical
Company
TAIWAN SURGICAL CORPORATION
Model
TSI-533
Device description
5mm x 33cm 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
04717480900435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04717480900435047174809004354717480900435

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
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00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30
B382SD13768330Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD9156321100Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD49195170Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
B382SD9039841050Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
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00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
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00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
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00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25