HELIPAQ HSR10072020

GUDID 00878528002857

HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 7mm x 20cm 190cm Contents: 1 Detachable Coil System

Medos International Sàrl

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil
Primary Device ID00878528002857
NIH Device Record Keybf187049-a809-48ac-b51a-2e6717b3dbe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHELIPAQ
Version Model NumberHSR100720-20
Catalog NumberHSR10072020
Company DUNS482661753
Company NameMedos International Sàrl
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100878528002857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-20

On-Brand Devices [HELIPAQ]

00878528002932HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 5mm x 20cm 190cm Contents: 1 Detachable Coil
00878528002925HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 10mm x 30cm 190cm Contents: 1 Detachable Coi
00878528002918HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 10mm x 20cm 190cm Contents: 1 Detachable Coi
00878528002901HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 9mm x 30cm 190cm Contents: 1 Detachable Coil
00878528002895HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 9mm x 20cm 190cm Contents: 1 Detachable Coil
00878528002888HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 8mm x 30cm 190cm Contents: 1 Detachable Coil
00878528002871HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 8mm x 20cm 190cm Contents: 1 Detachable Coil
00878528002864HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 7mm x 30cm 190cm Contents: 1 Detachable Coil
00878528002857HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 7mm x 20cm 190cm Contents: 1 Detachable Coil
00878528002840HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 6mm x 20cm 190cm Contents: 1 Detachable Coil
00878528002833HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 10mm x 15cm 190cm Contents: 1 Detachable Coi
00878528002826HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 9mm x 15cm 190cm Contents: 1 Detachable Coil
00878528002819HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 8mm x 15cm 190cm Contents: 1 Detachable Coil
00878528002802HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 8mm x 10cm 190cm Contents: 1 Detachable Coil
00878528002796HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 7mm x 15cm 190cm Contents: 1 Detachable Coil
00878528002789HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 7mm x 10cm 190cm Contents: 1 Detachable Coil
00878528002772HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 6mm x 15cm 190cm Contents: 1 Detachable Coil
00878528002765HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 6mm x 10cm 190cm Contents: 1 Detachable Coil
00878528002758HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 5mm x 15cm 190cm Contents: 1 Detachable Coil
00878528002741HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 5mm x 10cm 190cm Contents: 1 Detachable Coil
00878528002734HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 4mm x 10cm 190cm Contents: 1 Detachable Coil
00878528002727HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 4mm x 8cm 190cm Contents: 1 Detachable Coil
00878528002710HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 4mm x 6cm 190cm Contents: 1 Detachable Coil
00878528002703HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 4mm x 4cm 190cm Contents: 1 Detachable Coil
00878528002697HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 3mm x 10cm 190cm Contents: 1 Detachable Coil
00878528002680HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 3mm x 8cm 190cm Contents: 1 Detachable Coil
00878528002673HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 3mm x 6cm 190cm Contents: 1 Detachable Coil
00878528002666HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 3mm x 4cm 190cm Contents: 1 Detachable Coil
00878528002659HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 2mm x 8cm 190cm Contents: 1 Detachable Coil
00878528002642HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 2mm x 6cm 190cm Contents: 1 Detachable Coil
00878528002635HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 2mm x 4cm 190cm Contents: 1 Detachable Coil
00878528002628HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 2mm x 3cm 190cm Contents: 1 Detachable Coil
00878528002611HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 2mm x 2cm 190cm Contents: 1 Detachable Coil
00878528002604HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 2mm x 1cm 190cm Contents: 1 Detachable Coil
00878528002536HELIPAQ microcoil HELIPAQ 18 Platinum Coil 20mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002529HELIPAQ microcoil HELIPAQ 18 Platinum Coil 18mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002512HELIPAQ microcoil HELIPAQ 18 Platinum Coil 16mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002505HELIPAQ microcoil HELIPAQ 18 Platinum Coil 14mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002499HELIPAQ microcoil HELIPAQ 18 Platinum Coil 12mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002482HELIPAQ microcoil HELIPAQ 18 Platinum Coil 10mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002475HELIPAQ microcoil HELIPAQ 18 Platinum Coil 9mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002468HELIPAQ microcoil HELIPAQ 18 Platinum Coil 8mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002451HELIPAQ microcoil HELIPAQ 18 Platinum Coil 7mm x 30cm 190cm Contents: 1 Detachable Coil System
00878528002444HELIPAQ microcoil HELIPAQ 18 Platinum Coil 6mm x 20cm 190cm Contents: 1 Detachable Coil System
00878528002437HELIPAQ microcoil HELIPAQ 18 Platinum Coil 5mm x 15cm 190cm Contents: 1 Detachable Coil System
00878528002420HELIPAQ microcoil HELIPAQ 18 Platinum Coil 4mm x 10cm 190cm Contents: 1 Detachable Coil System
00878528002413HELIPAQ microcoil HELIPAQ 18 Platinum Coil 3mm x 8cm 190cm Contents: 1 Detachable Coil System
00878528002406HELIPAQ microcoil HELIPAQ 18 Platinum Coil 2mm x 4cm 190cm Contents: 1 Detachable Coil System

Trademark Results [HELIPAQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HELIPAQ
HELIPAQ
76217574 2667101 Live/Registered
DEPUY SYNTHES, INC.
2001-02-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.