Checkpoint Guardian 9095
GUDID B13090951
Handheld Single-use Surgical Nerve Stimulator
CHECKPOINT SURGICAL INC
Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system| Primary Device ID | B13090951 |
| NIH Device Record Key | f350ae6e-88b7-4d6f-a648-a53332cfda98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Checkpoint Guardian |
| Version Model Number | 9095 |
| Catalog Number | 9095 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B13090950 [Primary] |
| HIBCC | B13090951 [Package] Contains: B13090950 Package: pouch [1 Units] In Commercial Distribution |
| HIBCC | B13090952 [Package] Package: box [1 Units] In Commercial Distribution |
| HIBCC | B13090953 [Package] Contains: B13090952 Package: shipping carton [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092292
FDA Product Code
| ETN | Stimulator, Nerve |
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 | 2020-07-09 |
| Device Publish Date | 2020-07-01 |
Devices Manufactured by CHECKPOINT SURGICAL INC
| B13090951 - Checkpoint Guardian | 2020-07-09Handheld Single-use Surgical Nerve Stimulator |
| 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 | 2018-07-06 Surgical Nerve Stimulator/Locator |
Trademark Results [Checkpoint Guardian]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHECKPOINT GUARDIAN 88916274 not registered Live/Pending |
Checkpoint Surgical, Inc. 2020-05-14 |
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