Checkpoint Gemini 9092
GUDID B13090921
Handheld Single-use Surgical Bipolar Nerve Stimulator
Checkpoint Surgical, Inc.
Nerve-locating system| Primary Device ID | B13090921 |
| NIH Device Record Key | d83b782d-24f7-4d43-b9d5-528da7a6b1d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Checkpoint Gemini |
| Version Model Number | 9092 |
| Catalog Number | 9092 |
| 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
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com | |
| Phone | 216-378-9107 |
| regulatory@checkpointsurgical.com |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B13090920 [Primary] |
| HIBCC | B13090921 [Package] Contains: B13090920 Package: pouch [1 Units] In Commercial Distribution |
| HIBCC | B13090922 [Package] Package: box [1 Units] In Commercial Distribution |
| HIBCC | B13090923 [Package] Contains: B13090922 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 | 2022-04-07 |
| Device Publish Date | 2022-03-30 |
Devices Manufactured by Checkpoint Surgical, Inc.
| B130NS3020K23 - Checkpoint Nerve Repair Kit | 2023-09-11 The CHECKPOINT NERVE REPAIR KIT is a convenience kit of two (2) NeuroShield chitosan membranes (30mm x 20mm) and one (1) Checkpo |
| B130NS4030K13 - Checkpoint Nerve Repair Kit | 2023-09-11 The CHECKPOINT NERVE REPAIR KIT is a convenience kit of one (1) NeuroShield chitosan membrane (40mm x 30mm) and one (1) Checkpoi |
| B13095241 - Guardian Intraoperative Lead, Small | 2023-06-09 The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting ner |
| B130NS30201 - Checkpoint NeuroShield Chitosan Membrane | 2023-04-10 NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed |
| B130NS40300 - Checkpoint NeuroShield Chitosan Membrane | 2023-04-10 NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed |
| B130PV40301 - ProVeil Hydrogel Membrane | 2023-04-10 ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be a |
| B13095041 - Guardian Probe Extension, 12 cm | 2022-12-12 Probe Extension, 12 cm for use with Checkpoint Stimulators |
| B13095051 - Guardian Probe Extension Ball Tip, 12 cm | 2022-12-12 Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators |
Trademark Results [Checkpoint Gemini]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHECKPOINT GEMINI 97177542 not registered Live/Pending |
Checkpoint Surgical, Inc. 2021-12-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.