FDA.reportPublic FDA data

Flipper

Primary DI
00827002129122
Brand
Flipper
Company
William Cook Europe ApS
Model
G12912
Catalog number
FDW-35-80
Device description
Flipper, Delivery System
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002129122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002129122008270021291228270021291220827002129122

GMDN Terms#

Term, Definition table
TermDefinition
Embolization implant inserterA sterile, long, thin surgical device used to advance an embolization implant, e.g. an embolic coil, through the length of an appropriate catheter so that the implant is ready for discharge (implantation) when the catheter has been surgically positioned at the target site in an artery or vein. The inserter, also known as a pusher, is removed prior to the discharge of the implant. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
305302119
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002483033COOKG48303C-CAE-14.0-70-FIC2019-01-18
00827002236455COOKG23645C-CAE-14.0-70-FI2019-01-18
00827002236462COOKG23646C-CAE-14.0-70-FII2019-01-18
00827002535176COOKG53517C-CAE-14.0-70-FIC-SPOPS2019-01-18
00827002599109Zenith AlphaG59910ZTA2-P-46-179-W2024-12-03
00827002599123Zenith AlphaG59912ZTA2-P-46-233-W2024-12-03
00827002599154Zenith AlphaG59915ZTA2-P-40-117-W2024-12-03
00827002599185Zenith AlphaG59918ZTA2-P-40-142-W2024-12-03
00827002599215Zenith AlphaG59921ZTA2-P-40-167-W2024-12-03
00827002599239Zenith AlphaG59923ZTA2-P-40-217-W2024-12-03
00827002599260Zenith AlphaG59926ZTA2-P-42-121-W2024-12-03
00827002599321Zenith AlphaG59932ZTA2-P-42-173-W2024-12-03
00827002599352Zenith AlphaG59935ZTA2-P-42-225-W2024-12-03
00827002599383Zenith AlphaG59938ZTA2-P-44-125-W2024-12-03
00827002599413Zenith AlphaG59941ZTA2-P-44-152-W2024-12-03
00827002599444Zenith AlphaG59944ZTA2-P-44-179-W2024-12-03
00827002599475Zenith AlphaG59947ZTA2-P-44-233-W2024-12-03
00827002599505Zenith AlphaG59950ZTA2-P-46-125-W2024-12-03
00827002599567Zenith AlphaG59956ZTA2-P-24-105-W2024-12-03
00827002599581Zenith AlphaG59958ZTA2-P-24-127-W2024-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724255Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724262Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724279Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724286Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077046DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077077DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077176DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077183DELTAFILLCerenovus, Inc.KRD2016-11-16