FDA.reportPublic FDA data

Rebuilder Nerve Guidance Conduit

Primary DI
06975222390007
Brand
Rebuilder Nerve Guidance Conduit
Company
Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
Model
TG-015
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXICuff, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230794000Rebuilder Nerve Guidance ConduitCelestray Biotech Company, LLC.,2024-01-29JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975222390007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975222390007069752223900076975222390007

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, synthetic polymer, bioabsorbableAn implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
702939498
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975222391004SpinMedix® Absorbable Fibrous MembraneZK-0012025-05-20
06975222391011SpinMedix® Absorbable Fibrous MembraneZK-0022025-05-20
06975222391028SpinMedix® Absorbable Fibrous MembraneZK-0032025-05-20
06975222391035SpinMedix® Absorbable Fibrous MembraneZK-0042025-05-20
06975222391042SpinMedix® Absorbable Fibrous MembraneZK-0052025-05-20
06975222391059SpinMedix® Absorbable Fibrous MembraneZK-0062025-05-20
06975222391066SpinMedix® Absorbable Fibrous MembraneZK-0072025-05-20
06975222391073SpinMedix® Absorbable Fibrous MembraneZK-0082025-05-20
06975222391080SpinMedix® Absorbable Fibrous MembraneZK-0092025-05-20
06975222391097SpinMedix® Absorbable Fibrous MembraneZK-0102025-05-20
06975222391103SpinMedix® Absorbable Fibrous MembraneZK-0112025-05-20
06975222391110SpinMedix® Absorbable Fibrous MembraneZK-0122025-05-20
06975222391127SpinMedix® Absorbable Fibrous MembraneZK-0132025-05-20
06975222391134SpinMedix® Absorbable Fibrous MembraneZK-0142025-05-20
06975222391141SpinMedix® Absorbable Fibrous MembraneZK-0152025-05-20
06975222391158SpinMedix® Absorbable Fibrous MembraneZK-0162025-05-20
06975222391165SpinMedix® Absorbable Fibrous MembraneZK-0172025-05-20
06975222391172SpinMedix® Absorbable Fibrous MembraneZK-0182025-05-20
06975222391189SpinMedix® Absorbable Fibrous MembraneZK-0192025-05-20
06975222391196SpinMedix® Absorbable Fibrous MembraneZK-0202025-05-20

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