FDA.reportPublic FDA data

ReFeel

Primary DI
04987224802015
Brand
ReFeel
Company
MOCHIDA PHARMACEUTICAL CO., LTD.
Model
802-01
Published
2024-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K233322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233322000Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.2024-06-21JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987224802015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987224802015049872248020154987224802015

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
690543012
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B454VTP12G10VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-12-21
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-11-21
G517CW2040ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10
G517CW4080ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10
00813954027272Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027289Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027296Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027302Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027319Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027326Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027333Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027340Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027357Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027364Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027371Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027388Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
06975222390007Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390014Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390021Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390038Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390045Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390052Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390069Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390076Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390083Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390090Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
09358206000043Remplir™ORTHOCELL LIMITEDJXI2025-04-07
09358206000074Remplir™ORTHOCELL LIMITEDJXI2025-04-07
19358206000040Remplir™ORTHOCELL LIMITEDJXI2025-04-07
09358206000050Remplir™ORTHOCELL LIMITEDJXI2025-04-07