FDA.report

Inno-Port

Primary DI
04717480900121
Brand
Inno-Port
Company
TAIWAN SURGICAL CORPORATION
Model
DTW01-XB
Device description
Disposable Trocar, 5-11mm, Length 100mm, Bladeless (Obturator*1, Cannula*1)
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K223593000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04717480900121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04717480900121047174809001214717480900121

GMDN Terms

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

Regulatory Flags

DUNS number
657134172
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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04717480902354InnoClipRC5T1-BX2023-07-11
04717480906024SkinPlusDP0S1-SR2023-07-11
04717480906031SkinPlusDP0S1-SW2023-07-11
14717480902016InnoClipTDC-10-ML2023-07-11
14717480902023InnoClipTDC-10-L2023-07-11
14717480902306InnoClipTRC-H00002023-07-11
14717480902368InnoClipDC5T1-BX2023-07-11
14717480902375InnoClipDC5T1-B62023-07-11
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
04717480900060Inno-PortDT501-XL2023-06-07
04717480900077Inno-PortDT501-XP2023-06-07
04717480900084Inno-PortDT501-712023-06-07
04717480900138Inno-PortDTW01-XQ2023-06-07

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