DELTAPLUSH DPL10020120
GUDID 00878528008033
DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2mm x 1cm 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 ID | 00878528008033 |
| NIH Device Record Key | 15618071-80a6-4e13-8a83-a041e547e780 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DELTAPLUSH |
| Version Model Number | DPL100201-20 |
| Catalog Number | DPL10020120 |
| 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 |
| 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 |
| 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 |
| xx@xx.xx |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00878528008033 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142429
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-20 |
On-Brand Devices [DELTAPLUSH]
| 00878528008156 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 4mm x 8cm 190cm Contents: 1 Detachable |
| 00878528008149 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 4mm x 6cm 190cm Contents: 1 Detachable |
| 00878528008132 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 4mm x 4cm 190cm Contents: 1 Detachable |
| 00878528008125 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 3mm x 6cm 190cm Contents: 1 Detachable |
| 00878528008118 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 3mm x 4cm 190cm Contents: 1 Detachable |
| 00878528008101 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2.5mm x 6cm 190cm Contents: 1 Detachab |
| 00878528008095 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2.5mm x 4cm 190cm Contents: 1 Detachab |
| 00878528008088 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2.5mm x 2cm 190cm Contents: 1 Detachab |
| 00878528008071 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2mm x 6cm 190cm Contents: 1 Detachable |
| 00878528008064 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2mm x 4cm 190cm Contents: 1 Detachable |
| 00878528008057 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2mm x 3cm 190cm Contents: 1 Detachable |
| 00878528008040 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2mm x 2cm 190cm Contents: 1 Detachable |
| 00878528008033 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2mm x 1cm 190cm Contents: 1 Detachable |
| 00878528008026 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 1.5mm x 3cm 190cm Contents: 1 Detachab |
| 00878528008019 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 1.5mm x 2cm 190cm Contents: 1 Detachab |
| 00878528008002 | DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 1.5mm x 1cm 190cm Contents: 1 Detachab |
Trademark Results [DELTAPLUSH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELTAPLUSH 77600360 3719772 Live/Registered |
DEPUY SYNTHES, INC. 2008-10-24 |
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