Checkpoint Gemini 9092

GUDID B13090921

Handheld Single-use Surgical Bipolar Nerve Stimulator

Checkpoint Surgical, Inc.

Nerve-locating system
Primary Device IDB13090921
NIH Device Record Keyd83b782d-24f7-4d43-b9d5-528da7a6b1d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCheckpoint Gemini
Version Model Number9092
Catalog Number9092
Company DUNS832575364
Company NameCheckpoint Surgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com
Phone216-378-9107
Emailregulatory@checkpointsurgical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB13090920 [Primary]
HIBCCB13090921 [Package]
Contains: B13090920
Package: pouch [1 Units]
In Commercial Distribution
HIBCCB13090922 [Package]
Package: box [1 Units]
In Commercial Distribution
HIBCCB13090923 [Package]
Contains: B13090922
Package: shipping carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNStimulator, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-07
Device Publish Date2022-03-30

Devices Manufactured by Checkpoint Surgical, Inc.

B130NS3020K23 - Checkpoint Nerve Repair Kit2023-09-11 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 Kit2023-09-11 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, Small2023-06-09 The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting ner
B130NS30201 - Checkpoint NeuroShield Chitosan Membrane2023-04-10 NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed
B130NS40300 - Checkpoint NeuroShield Chitosan Membrane2023-04-10 NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed
B130PV40301 - ProVeil Hydrogel Membrane2023-04-10 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 cm2022-12-12 Probe Extension, 12 cm for use with Checkpoint Stimulators
B13095051 - Guardian Probe Extension Ball Tip, 12 cm2022-12-12 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
CHECKPOINT GEMINI
97177542 not registered Live/Pending
Checkpoint Surgical, Inc.
2021-12-17

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