TRUFILL DCS ORBIT 637HF0204
GUDID 10886704029663
TRUFILL DCS ORBIT Detachable Coil 175cm 2mm x 4cm Coil Type: Helical Fill
CODMAN & SHURTLEFF, INC.
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 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 | 10886704029663 |
| NIH Device Record Key | ed031320-0d26-4745-a05f-f97eed77b355 |
| Commercial Distribution Discontinuation | 2020-12-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TRUFILL DCS ORBIT |
| Version Model Number | 637HF0204 |
| Catalog Number | 637HF0204 |
| Company DUNS | 607846297 |
| Company Name | CODMAN & SHURTLEFF, INC. |
| 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 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886704029663 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123560
FDA Product Code
| HCG | DEVICE, NEUROVASCULAR 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 | 2022-01-28 |
| Device Publish Date | 2015-09-20 |
On-Brand Devices [TRUFILL DCS ORBIT]
| 10886704029755 | TRUFILL DCS ORBIT Detachable Coil 175cm 5mm x 12cm Coil Type: Helical Fill |
| 10886704030140 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=18mm 30cm Co |
| 10886704029816 | TRUFILL DCS ORBIT Detachable Coil 175cm 12mm x 30cm Coil Type: Helical Fill |
| 10886704029809 | TRUFILL DCS ORBIT Detachable Coil 175cm 10mm x 30cm Coil Type: Helical Fill |
| 10886704029793 | TRUFILL DCS ORBIT Detachable Coil 175cm 9mm x 30cm Coil Type: Helical Fill |
| 10886704030171 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=4mm 10cm Coi |
| 10886704030164 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=4mm 7cm Coil |
| 10886704030157 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=20mm 30cm Co |
| 10886704030133 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=16mm 30cm Co |
| 10886704030126 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=14mm 30cm Co |
| 10886704030119 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=12mm 30cm Co |
| 10886704030102 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=10mm 30cm Co |
| 10886704030096 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=9mm 25cm Coi |
| 10886704030089 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=8mm 24cm Coi |
| 10886704030072 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=7mm 21cm Coi |
| 10886704030065 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=6mm 15cm Coi |
| 10886704030058 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=12mm 30cm Co |
| 10886704030041 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=10mm 30cm Co |
| 10886704030034 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=9mm 25cm Coi |
| 10886704030027 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=8mm 24cm Coi |
| 10886704030010 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=7mm 21cm Coi |
| 10886704030003 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=6mm 15cm Coi |
| 10886704029991 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=5mm 15cm Coi |
| 10886704029984 | TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=5mm 10cm Coi |
| 10886704029953 | TRUFILL DCS ORBIT Detachable Coil 175cm 3.5mm x 7.5cm Coil Type: Mini Complex Fill |
| 10886704029946 | TRUFILL DCS ORBIT Detachable Coil 175cm 3.5mm x 9cm Coil Type: Mini Complex Fill |
| 10886704029939 | TRUFILL DCS ORBIT Detachable Coil 175cm 3.5mm x 5cm Coil Type: Mini Complex Fill |
| 10886704029922 | TRUFILL DCS ORBIT Detachable Coil 175cm 2.5mm x 4.5cm Coil Type: Mini Complex Fill |
| 10886704029915 | TRUFILL DCS ORBIT Detachable Coil 175cm 2.5mm x 3.5cm Coil Type: Mini Complex Fill |
| 10886704029908 | TRUFILL DCS ORBIT Detachable Coil 175cm 2.5mm x 2.5cm Coil Type: Mini Complex Fill |
| 10886704029892 | TRUFILL DCS ORBIT Detachable Coil 175cm 4mm x 10cm Coil Type: Mini Complex Fill |
| 10886704029885 | TRUFILL DCS ORBIT Detachable Coil 175cm 4mm x 7cm Coil Type: Mini Complex Fill |
| 10886704029878 | TRUFILL DCS ORBIT Detachable Coil 175cm 4mm x 3cm Coil Type: Mini Complex Fill |
| 10886704029861 | TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 6cm Coil Type: Mini Complex Fill |
| 10886704029854 | TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 4cm Coil Type: Mini Complex Fill |
| 10886704029847 | TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 3cm Coil Type: Mini Complex Fill |
| 10886704029830 | TRUFILL DCS ORBIT Detachable Coil 175cm 2mm x 2cm Coil Type: Mini Complex Fill |
| 10886704029823 | TRUFILL DCS ORBIT Detachable Coil 175cm 2mm x 1.5cm Coil Type: Mini Complex Fill |
| 10886704029786 | TRUFILL DCS ORBIT Detachable Coil 175cm 8mm x 30cm Coil Type: Helical Fill |
| 10886704029779 | TRUFILL DCS ORBIT Detachable Coil 175cm 7mm x 15cm Coil Type: Helical Fill |
| 10886704029762 | TRUFILL DCS ORBIT Detachable Coil 175cm 6mm x 15cm Coil Type: Helical Fill |
| 10886704029748 | TRUFILL DCS ORBIT Detachable Coil 175cm 4mm x 8cm Coil Type: Helical Fill |
| 10886704029731 | TRUFILL DCS ORBIT Detachable Coil 175cm 4mm x 6cm Coil Type: Helical Fill |
| 10886704029724 | TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 10cm Coil Type: Helical Fill |
| 10886704029717 | TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 8cm Coil Type: Helical Fill |
| 10886704029700 | TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 6cm Coil Type: Helical Fill |
| 10886704029694 | TRUFILL DCS ORBIT Detachable Coil 175cm 3mm x 4cm Coil Type: Helical Fill |
| 10886704029687 | TRUFILL DCS ORBIT Detachable Coil 175cm 2mm x 8cm Coil Type: Helical Fill |
| 10886704029670 | TRUFILL DCS ORBIT Detachable Coil 175cm 2mm x 6cm Coil Type: Helical Fill |
| 10886704029656 | TRUFILL DCS ORBIT Detachable Coil 175cm 2mm x 2cm Coil Type: Helical Fill |
Trademark Results [TRUFILL DCS ORBIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUFILL DCS ORBIT 76637115 3398898 Live/Registered |
DEPUY SYNTHES, INC. 2005-04-26 |
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