FDA.report

InnoClip

Primary DI
04717480902354
Brand
InnoClip
Company
TAIWAN SURGICAL CORPORATION
Model
RC5T1-BX
Device description
Titanium Clip Cartridge, 5mm, Titanium, ML, 10 Clips
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
true
Single use
true

Related Records

Product Codes

CodeName
FZPClip, Implantable

Product Code Classifications

CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

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
04717480902354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04717480902354047174809023544717480902354

GMDN Terms

TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

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

Primary DIBrandModelCatalogPublished
04717480900374Taiwan SurgicalTSR-120-R2023-08-02
04717480902347InnoClipRC5T1-B62023-07-11
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
04717480900121Inno-PortDTW01-XB2023-06-07
04717480900138Inno-PortDTW01-XQ2023-06-07

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