ORBIT GALAXY ENPOWER 641CF1230

GUDID 10878528009662

ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology 12mm x 30cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology

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

Primary Device ID	10878528009662
NIH Device Record Key	cb88c9a9-1a44-4d06-9e35-e28c8e1879f6
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORBIT GALAXY ENPOWER
Version Model Number	641CF1230
Catalog Number	641CF1230
Company DUNS	482661753
Company Name	Medos International Sàrl
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10878528009662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142429

FDA Product Code

KRD	Device, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-02-05
Device Publish Date	2015-09-20

On-Brand Devices [ORBIT GALAXY ENPOWER]

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10878528009594	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology
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10878528009556	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology
10878528009549	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology
10878528009532	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology
10878528009525	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 3.5mm x 9cm 190cm Contents: 1 Deta
10878528009495	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 3.5mm x 7.5cm 190cm Contents: 1 De
10878528009488	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 3mm x 8cm 190cm Contents: 1 Detach
10878528009471	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 3mm x 6cm 190cm Contents: 1 Detach
10878528009464	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 3mm x 4cm 190cm Contents: 1 Detach
10878528009457	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 2.5mm x 5cm 190cm Contents: 1 Deta
10878528009440	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 2.5mm x 3.5cm 190cm Contents: 1 De
10878528009433	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 2mm x 2cm 190cm Contents: 1 Detach
10878528009426	ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 2mm x 1.5cm 190cm Contents: 1 Deta