PhotonBlade™ PB1
GUDID 00816728020158
he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
INVUITY, INC.
Open-surgery electrosurgical electrode, monopolar, single-use| Primary Device ID | 00816728020158 |
| NIH Device Record Key | 24f0f79b-598c-4ffa-a750-91bd3f0b18c7 |
| Commercial Distribution Discontinuation | 2017-06-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PhotonBlade™ |
| Version Model Number | PB1 |
| Catalog Number | PB1 |
| Company DUNS | 175697908 |
| Company Name | INVUITY, INC. |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816728020158 [Primary] |
| GS1 | 00816728020639 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162053
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2017-02-07 |
On-Brand Devices [PhotonBlade™]
| 00816728020158 | he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagu |
| 00816728021094 | he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagu |
Trademark Results [PhotonBlade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHOTONBLADE 87017629 5210744 Live/Registered |
INVUITY, INC. 2016-04-28 |
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