SapphireTM

GUDID 00836462008243

SDS-1 SAPPHIRE DETACHMENT SYS

Micro Therapeutics, Inc.

Vascular implant detacher, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable Vascular implant detacher, electronic, reusable

Primary Device ID	00836462008243
NIH Device Record Key	6ba892d0-d7b4-4714-9ec6-babe2463de20
Commercial Distribution Status	In Commercial Distribution
Brand Name	SapphireTM
Version Model Number	SDS-1
Company DUNS	826110710
Company Name	Micro Therapeutics, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
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	false
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)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry and secure location

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462008243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K030392

FDA Product Code

HCG	DEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

[00836462008243]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-10-02

Devices Manufactured by Micro Therapeutics, Inc.

00847536036215 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-10 V03 VANTAGE
00847536036222 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-12 V03 VANTAGE
00847536036239 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-14 V03 VANTAGE
00847536036246 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-16 V03 VANTAGE
00847536036253 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-18 V03 VANTAGE
00847536036260 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-20 V03 VANTAGE
00847536036277 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-275-10 V03 VANTAGE
00847536036284 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-275-12 V03 VANTAGE