FDA.report

InnoClip

Primary DI
14717480902306
Brand
InnoClip
Company
TAIWAN SURGICAL CORPORATION
Model
TRC-H0000
Device description
Reusable Clip Applier Handle
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GDOApplier, Surgical, Clip

Product Code Classifications

CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Premarket Submissions

SubmissionSupplement
K202994000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K202994000InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation2022-01-04FZP

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14717480902306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1471748090230614717480902306

GMDN Terms

TermDefinition
Ligation clip cartridge holderA device designed to hold sterile ligation clip cartridges to facilitate quick reloading of the cartridges into a surgical clip applier during a surgical procedure. It is typically made of metal and plastic materials in the form of a flat and stable base with profiled slots in its upper surface into which many ligation clip cartridges are held ready for loading. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04717480900374Taiwan SurgicalTSR-120-R2023-08-02
04717480902347InnoClipRC5T1-B62023-07-11
04717480902354InnoClipRC5T1-BX2023-07-11
04717480906024SkinPlusDP0S1-SR2023-07-11
04717480906031SkinPlusDP0S1-SW2023-07-11
14717480902016InnoClipTDC-10-ML2023-07-11
14717480902023InnoClipTDC-10-L2023-07-11
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
04717480900121Inno-PortDTW01-XB2023-06-07
04717480900138Inno-PortDTW01-XQ2023-06-07

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