ProVeil Hydrogel Membrane

Basic Information

• Brand Name: ProVeil Hydrogel Membrane
• Primary DI: B130PV40300
• Version / Model: PV4030
• Catalog Number: PV4030
• Company Name: Checkpoint Surgical, Inc.
• Labeler DUNS: 832575364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-31
• Public Version: 1
• Public Version Date: 2023-04-10
• Public Version Status: New
• Public Device Record Key: 4612a465-e744-4129-89ff-10a982219dd6

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXI	Cuff, Nerve	Neurology	882.5275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43233	Nerve guide, bioabsorbable, animal-derived	An implantable tubular device intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is made of an animal-derived material (e.g., porcine-derived collagen matrix, chitosan) that can be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B130PV40301	HIBCC	Pouch	1	In Commercial Distribution
Primary	B130PV40300	HIBCC
Package	B130PV40302	HIBCC	Sales Carton	1	In Commercial Distribution
Package	B130PV40303	HIBCC	Shipping Box	20	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190246	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit