FDA.reportPublic FDA data

Checkpoint Nerve Repair Kit

Primary DI
B130NS4030K13
Brand
Checkpoint Nerve Repair Kit
Company
Checkpoint Surgical, Inc.
Model
NS4030K1
Catalog number
NS4030K1
Device description
The CHECKPOINT NERVE REPAIR KIT is a convenience kit of one (1) NeuroShield chitosan membrane (40mm x 30mm) and one (1) Checkpoint Edge Nerve Cutting Kit.
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B130NS4030K13PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, single-useA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2163789107regulatory@checkpointsurgical.com

Regulatory Flags#

DUNS number
832575364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B130NS30200Checkpoint NeuroShield Chitosan MembraneNS3020NS30202023-03-31
B130PV40300ProVeil Hydrogel MembranePV4030PV40302023-03-31
B130NS3020K23Checkpoint Nerve Repair KitNS3020K2NS3020K22023-09-01
B130NS40300Checkpoint NeuroShield Chitosan MembraneNS4030NS40302023-03-31
B13095240Guardian Intraoperative Lead, Small952495242023-06-01
B13095241Guardian Intraoperative Lead, Small952495242023-06-01
B130NS30201Checkpoint NeuroShield Chitosan MembraneNS3020NS30202023-03-31
B130PV40301ProVeil Hydrogel MembranePV4030PV40302023-03-31
B13095040Guardian Probe Extension, 12 cm950495042022-12-02
B13095050Guardian Probe Extension Ball Tip, 12 cm950595052022-12-02
B13095060Guardian Probe Extension, 4 cm950695062022-12-02
B13095041Guardian Probe Extension, 12 cm950495042022-12-02
B13095051Guardian Probe Extension Ball Tip, 12 cm950595052022-12-02
B13095061Guardian Probe Extension, 4 cm950695062022-12-02
B13092500Checkpoint Edge Nerve Cutting Kit925092502022-05-09
B13092501Checkpoint Edge Nerve Cutting Kit925092502022-05-09
B13090920Checkpoint Gemini909290922022-03-30
B13090921Checkpoint Gemini909290922022-03-30
B13095250Guardian Intraoperative Lead, Medium952595252021-09-02
B13095251Guardian Intraoperative Lead, Medium952595252021-09-02