DELTAPAQ DFS10102520
GUDID 00878528007999
DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System
Medos International Sàrl
Neurovascular embolization coil| Primary Device ID | 00878528007999 |
| NIH Device Record Key | 6ead1bef-44d6-4dfd-9468-34bae4f0d166 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DELTAPAQ |
| Version Model Number | DFS101025-20 |
| Catalog Number | DFS10102520 |
| 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 |
| 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 |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00878528007999 [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 [DELTAPAQ]
| 00878528007999 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 10mm x 25cm 190cm Contents: 1 Detachable C |
| 00878528007968 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 9mm x 25cm 190cm Contents: 1 Detachable Co |
| 00878528007937 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 8mm x 20cm 190cm Contents: 1 Detachable Co |
| 00878528007890 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 20cm 190cm Contents: 1 Detachable Co |
| 00878528007883 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 16cm 190cm Contents: 1 Detachable Co |
| 00878528007852 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 6mm x 16cm 190cm Contents: 1 Detachable Co |
| 00878528007845 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 6mm x 12cm 190cm Contents: 1 Detachable Co |
| 00878528007807 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 5mm x 15cm 190cm Contents: 1 Detachable Co |
| 00878528007791 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 5mm x 10cm 190cm Contents: 1 Detachable Co |
| 00878528007760 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 10cm 190cm Contents: 1 Detachable Co |
| 00878528007753 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 8cm 190cm Contents: 1 Detachable Coi |
| 00878528007746 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 4mm x 6cm 190cm Contents: 1 Detachable Coi |
| 00878528007715 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 10cm 190cm Contents: 1 Detachable Co |
| 00878528007708 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 8cm 190cm Contents: 1 Detachable Coi |
| 00878528007692 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 6cm 190cm Contents: 1 Detachable Coi |
| 00878528007685 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 4cm 190cm Contents: 1 Detachable Coi |
| 00878528007661 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 10cm 190cm Contents: 1 Detachable |
| 00878528007654 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 8cm 190cm Contents: 1 Detachable C |
| 00878528007647 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 6cm 190cm Contents: 1 Detachable C |
| 00878528007630 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 4cm 190cm Contents: 1 Detachable C |
| 00878528007623 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2.5mm x 2cm 190cm Contents: 1 Detachable C |
| 00878528007616 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 10cm 190cm Contents: 1 Detachable Co |
| 00878528007609 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 8cm 190cm Contents: 1 Detachable Coi |
| 00878528007593 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 6cm 190cm Contents: 1 Detachable Coi |
| 00878528007586 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 4cm 190cm Contents: 1 Detachable Coi |
| 00878528007579 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 3cm 190cm Contents: 1 Detachable Coi |
| 00878528007562 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 2cm 190cm Contents: 1 Detachable Coi |
| 00878528007548 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 6cm 190cm Contents: 1 Detachable C |
| 00878528007531 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 4cm 190cm Contents: 1 Detachable C |
| 00878528007517 | DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 1.5mm x 2cm 190cm Contents: 1 Detachable C |
Trademark Results [DELTAPAQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELTAPAQ 77389359 3706077 Live/Registered |
DEPUY SYNTHES, INC. 2008-02-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.