| Primary Device ID | B13093941 |
| NIH Device Record Key | cc361bda-6602-4973-a07e-6b21dd9425c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Checkpoint Head & Neck |
| Version Model Number | 9394 |
| Company DUNS | 832575364 |
| Company Name | CHECKPOINT SURGICAL 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 |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| info@checkpointsurgical.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B13093941 [Primary] |
| HIBCC | B13093942 [Package] Package: [1 Units] In Commercial Distribution |
| HIBCC | B13093943 [Package] Contains: B13093942 Package: Carton [4 Units] In Commercial Distribution |
| ETN | Stimulator, Nerve |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-18 |
| B13090951 - Checkpoint Guardian | 2020-07-09 Handheld Single-use Surgical Nerve Stimulator |
| B13090941 - Checkpoint | 2018-07-06 Surgical Nerve Stimulator/Locator |
| B13093941 - Checkpoint Head & Neck | 2018-07-06Surgical Nerve Stimulator/Locator |
| B13093941 - Checkpoint Head & Neck | 2018-07-06 Surgical Nerve Stimulator/Locator |