FDA.report

Flipper

Primary DI
00827002129139
Brand
Flipper
Company
William Cook Europe ApS
Model
G12913
Catalog number
FDW-35-110
Device description
Flipper, Delivery System
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications

CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002129139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002129139008270021291398270021291390827002129139

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
305302119
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

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