FDA.report

INT or KDL

Primary DI
26950900961971
Brand
INT or KDL
Company
Shanghai Kindly Medical Instruments Co., Ltd.
Model
NIS04
Device description
Interventional radiology percutaneous-access procedure kit.
Published
2023-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DYBIntroducer, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
26950900961971PackageGS15In Commercial Distribution
46950900961975PackageGS1200In Commercial Distribution
06950900961977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2695090096197126950900961971
4695090096197546950900961975
06950900961977069509009619776950900961977

GMDN Terms

TermDefinition
Interventional radiology percutaneous-access kit, single-useA collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
420827639
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
26950900900697INT,SlideCathACJL605F11252023-09-11
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26950900900772INT,SlideCathACJR455F11002023-09-11
26950900900789INT,SlideCathACJR456F11002023-09-11
26950900900796INT,SlideCathACJR456F11252023-09-11
26950900900802INT,SlideCathACJR457F11002023-09-11
26950900900819INT,SlideCathACJR505F11252023-09-11
26950900900826INT,SlideCathACJR506F11252023-09-11
26950900900833INT,SlideCathACJR605F11252023-09-11
26950900900840INT,SlideCathACJR606F11252023-09-11
26950900900857INT,SlideCathACTIG24F11002023-09-11
26950900900864INT,SlideCathACTIG25F11002023-09-11
26950900900871INT,SlideCathACTIG27F11002023-09-11
26950900900888INT,SlideCathACTIG34F11002023-09-11

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