DELTAPLUSH DPL10020220
GUDID 00878528008040
DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 2mm x 2cm 190cm Contents: 1 Detachable Coil System
Medos International Sàrl
Neurovascular embolization coil| Primary Device ID | 00878528008040 |
| NIH Device Record Key | e0ecad9f-b91c-437e-bdf4-ea151c9844c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DELTAPLUSH |
| Version Model Number | DPL100202-20 |
| Catalog Number | DPL10020220 |
| 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
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| 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 | 00878528008040 [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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