Inno-Port

Primary DI
04717480900060
Brand
Inno-Port
Company
TAIWAN SURGICAL CORPORATION
Model
DT501-XL
Device description
Disposable Trocar, 5mm, Length 100mm, Bladeless (Obturator*1, Cannula*2)
Published
2023-06-07
Public version status
New
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
K223593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223593000Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical TrocarTaiwan Surgical Corporation2023-03-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04717480900060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04717480900060047174809000604717480900060

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. 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
04717480902347InnoClipRC5T1-B62023-07-11
04717480902354InnoClipRC5T1-BX2023-07-11
14717480902016InnoClipTDC-10-ML2023-07-11
14717480902023InnoClipTDC-10-L2023-07-11
14717480902306InnoClipTRC-H00002023-07-11
14717480902368InnoClipDC5T1-BX2023-07-11
14717480902375InnoClipDC5T1-B62023-07-11
04717480900428Taiwan SurgicalTSI-5452023-06-07
04717480900435Taiwan SurgicalTSI-5332023-06-07
04717480900374Taiwan SurgicalTSR-120-R2023-08-02
04717480906024SkinPlusDP0S1-SR2023-07-11
04717480906031SkinPlusDP0S1-SW2023-07-11
04717480900008Inno-PortDT501-7B2023-06-07
04717480900015Inno-PortDT501-7Q2023-06-07
04717480900022Inno-PortDT501-XB2023-06-07
04717480900039Inno-PortDT501-XQ2023-06-07
04717480900046Inno-PortDT501-7L2023-06-07
04717480900053Inno-PortDT501-7P2023-06-07
04717480900077Inno-PortDT501-XP2023-06-07
04717480900084Inno-PortDT501-712023-06-07

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