SavvyWire F3001
GUDID 07540184130016
Pre-Shaped Pressure Guidewire
Opsens Inc
Cardiac/peripheral vascular guidewire, single-use| Primary Device ID | 07540184130016 |
| NIH Device Record Key | 042f331e-ed0d-4ace-8d29-595020daaf4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SavvyWire |
| Version Model Number | X-Small |
| Catalog Number | F3001 |
| Company DUNS | 253717946 |
| Company Name | Opsens Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com | |
| Phone | 1-833-677-3671 |
| info@opsens-medical.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540184030019 [Primary] |
| GS1 | 07540184130016 [Package] Contains: 07540184030019 Package: carton box [5 Units] In Commercial Distribution |
| GS1 | 07540184230013 [Package] Contains: 07540184030019 Package: shipping box [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213854
FDA Product Code
| DQX | Wire, Guide, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-21 |
| Device Publish Date | 2023-04-13 |
On-Brand Devices [SavvyWire]
| 07540184130023 | Pre-Shaped Pressure Guidewire |
| 07540184130016 | Pre-Shaped Pressure Guidewire |
Trademark Results [SavvyWire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAVVYWIRE 90030655 not registered Live/Pending |
OPSENS INC. 2020-07-01 |
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