Checkpoint NeuroShield Chitosan Membrane NS3020

GUDID B130NS30201

NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.

Checkpoint Surgical, Inc.

Nerve guide, bioabsorbable, animal-derived
Primary Device IDB130NS30201
NIH Device Record Keya15e54da-e19d-4647-b409-4ef1fbe655df
Commercial Distribution StatusIn Commercial Distribution
Brand NameCheckpoint NeuroShield Chitosan Membrane
Version Model NumberNS3020
Catalog NumberNS3020
Company DUNS832575364
Company NameCheckpoint Surgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
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
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
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
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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB130NS30200 [Primary]
HIBCCB130NS30201 [Package]
Contains: B130NS30200
Package: Pouch [1 Units]
In Commercial Distribution
HIBCCB130NS30202 [Package]
Package: Sales Carton [1 Units]
In Commercial Distribution
HIBCCB130NS30203 [Package]
Contains: B130NS30202
Package: Shipping Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXICuff, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-03-31

On-Brand Devices [Checkpoint NeuroShield Chitosan Membrane]

B130NS40300NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral ne
B130NS30201NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral ne

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