ULTIPAQ FSR10020120
GUDID 00878528001508
ULTIPAQ microcoil ULTIPAQ 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 | 00878528001508 |
| NIH Device Record Key | c18b722e-4b74-4acd-bdb5-6426a439c0a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ULTIPAQ |
| Version Model Number | FSR100201-20 |
| Catalog Number | FSR10020120 |
| 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage 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 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 |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00878528001508 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142429
FDA Product Code
| KRD | Device, Vascular, for Promoting 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 [ULTIPAQ]
| 00878528001676 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 4mm x 8cm 190cm Contents: 1 Detachable Coil |
| 00878528001669 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 4mm x 6cm 190cm Contents: 1 Detachable Coil |
| 00878528001652 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 4mm x 4cm 190cm Contents: 1 Detachable Coil |
| 00878528001645 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 4mm x 2cm 190cm Contents: 1 Detachable Coil |
| 00878528001638 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 3mm x 8cm 190cm Contents: 1 Detachable Coil |
| 00878528001621 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 3mm x 6cm 190cm Contents: 1 Detachable Coil |
| 00878528001614 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 3mm x 4cm 190cm Contents: 1 Detachable Coil |
| 00878528001607 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 3mm x 2cm 190cm Contents: 1 Detachable Coil |
| 00878528001591 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2.5mm x 8cm 190cm Contents: 1 Detachable Coi |
| 00878528001584 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2.5mm x 6cm 190cm Contents: 1 Detachable Coi |
| 00878528001577 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2.5mm x 4cm 190cm Contents: 1 Detachable Coi |
| 00878528001560 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2.5mm x 2cm 190cm Contents: 1 Detachable Coi |
| 00878528001553 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2mm x 8cm 190cm Contents: 1 Detachable Coil |
| 00878528001546 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2mm x 6cm 190cm Contents: 1 Detachable Coil |
| 00878528001539 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2mm x 4cm 190cm Contents: 1 Detachable Coil |
| 00878528001522 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2mm x 3cm 190cm Contents: 1 Detachable Coil |
| 00878528001515 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2mm x 2cm 190cm Contents: 1 Detachable Coil |
| 00878528001508 | ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2mm x 1cm 190cm Contents: 1 Detachable Coil |
Trademark Results [ULTIPAQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTIPAQ 76414295 2813812 Live/Registered |
DEPUY SYNTHES, INC. 2002-05-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.