Home GUDID 00827002087828 Silhouette
Primary DI 00827002087828
Brand Silhouette
Company COOK INCORPORATED
Model G08782
Catalog number PLVTW-24.0-38-30
Device description Silhouette, Transitionless Peel-Away, Introducer
Published 2016-09-24
Public version status Update
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 Code Name DYB INTRODUCER, CATHETER KGZ ACCESSORIES, CATHETER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2 KGZ Accessories, Catheter General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00827002087828 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00827002087828 00827002087828 827002087828 0827002087828
GMDN Terms# Term, Definition table Term Definition Interventional radiology percutaneous-access procedure kit A collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark, dry, cool place.
Regulatory Flags# DUNS number 042823948 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06976712970341 Hemo Luer Lock Micro-Energy Medical Technology Co., Ltd KGZ 2026-07-13 10884450114008 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-06-09 10884450119799 Prelude EASE™ Merit Medical Systems, Inc. DYB 2026-06-09 10884450114855 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-06-08 H787TDST0 AngioDynamics Angiodynamics, Inc. KGZ 2026-06-04 00850084947001 Genie MAX CULTIV8 1, LLC DYB 2026-05-29 G440VIZ1750 Multiflex Vizaramed, Inc. DYB 2026-04-09 10198459435201 MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. KGZ 2025-07-21 10192253053609 Devon Cardinal Health 200, LLC KGZ 2025-03-25 10192253042023 Devon Cardinal Health 200, LLC KGZ 2025-03-07 10192253042030 Devon Cardinal Health 200, LLC KGZ 2025-03-07 10193489068245 NAMIC MEDLINE INDUSTRIES, INC. KGZ 2023-12-21 10193489068108 MEDLINE MEDLINE INDUSTRIES, INC. KGZ 2023-09-18 10193489068115 MEDLINE MEDLINE INDUSTRIES, INC. KGZ 2023-09-18 10193489068122 MEDLINE MEDLINE INDUSTRIES, INC. KGZ 2023-09-18 10193489140187 MEDLINE MEDLINE INDUSTRIES, INC. KGZ 2023-09-18 10193489140194 MEDLINE MEDLINE INDUSTRIES, INC. KGZ 2023-09-18 10195594230456 CARDINAL HEALTH Cardinal Health 200, LLC KGZ 2021-08-16 08033003344965 NI-FLEX H.S. HOSPITAL SERVICE SPA KGZ 2021-03-01 10080196994007 Medline MEDLINE INDUSTRIES, INC. KGZ 2021-02-04 10193489191868 MEDLINE MEDLINE INDUSTRIES, INC. KGZ 2020-04-20 H862PS21SNC0 Posi-Stick Introducer Set URESIL, LLC KGZ 2019-06-19 08498840011300 VYGON Vygon Corporation DYB 2019-04-08 08498840011317 VYGON Vygon Corporation DYB 2019-04-08 08498840011751 VYGON Vygon Corporation DYB 2019-04-08 08498840011768 VYGON Vygon Corporation DYB 2019-04-08 08498840011775 VYGON Vygon Corporation DYB 2019-04-08 08498840011782 VYGON Vygon Corporation DYB 2019-04-08 08498840011799 VYGON Vygon Corporation DYB 2019-04-08 08498840011805 VYGON Vygon Corporation DYB 2019-04-08
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