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 |
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 |
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 | 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 |
ETN | Stimulator, Nerve |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-07 |
Device Publish Date | 2022-03-30 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CHECKPOINT GEMINI 97177542 not registered Live/Pending |
Checkpoint Surgical, Inc. 2021-12-17 |