symphonX™ 314-302
GUDID 08719324463096
The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).
Fortimedix Surgical B.V.
Surgical instrument handle, non-torque-limiting| Primary Device ID | 08719324463096 |
| NIH Device Record Key | 38665386-32c1-4a19-8f27-c1bae5a7eee0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | symphonX™ |
| Version Model Number | Handle with ratchet |
| Catalog Number | 314-302 |
| Company DUNS | 492888563 |
| Company Name | Fortimedix Surgical B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com | |
| Phone | +31454047470 |
| saleseurope@fortimedix.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 28 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08719324463096 [Primary] |
FDA Product Code
| GCJ | Laparoscope, General & Plastic Surgery |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
[08719324463096]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-15 |
| Device Publish Date | 2018-11-28 |
On-Brand Devices [symphonX™]
| 08719324463355 | Device for cutting or coagulating tissue; to be used in combination with an electrosurgical gene |
| 08719324463348 | Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to |
| 08719324463331 | Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratch |
| 08719324463324 | Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, H |
| 08719324463317 | Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratc |
| 08719324463072 | Device for use in combination with the symphonX Introducer during minimally invasive abdominal l |
| 08719324463065 | Device for irrigating/ aspirating |
| 08719324463058 | Device for cutting or coagulating tissue; to be used in combination with an electrosurgical gene |
| 08719324463041 | Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to |
| 08719324463034 | Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratch |
| 08719324463027 | Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, H |
| 08719324463119 | Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratc |
| 08719324463102 | The symphonX™ Handle with on/off ratchet is for use in combination with the symphonX™ Instru |
| 08719324463096 | The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments o |
| 08719324463089 | The symphonX™ Handle is for use in combination with the symphonX™ Instruments of the types: |
| 08719324463003 | The symphonX™ Introducer is intended to establish a path of entry for laparoscopic Instruments |
| 08719324463201 | The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introd |
| 08719324463195 | The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introd |
| 08719324463188 | The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the tro |
Trademark Results [symphonX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMPHONX 87172320 5338097 Live/Registered |
Fortimedix Surgical B.V. 2016-09-15 |
 SYMPHONX 79302302 not registered Live/Pending |
FUJIFILM Diosynth Biotechnologies UK Limited 2020-07-09 |
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