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
00810179630065AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630089AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630102AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630126AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630140AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630164AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630188AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630201AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630225AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630263AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630287AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630300AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630324AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630348AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630362AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630386AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630409AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630423AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630447AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630461AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630478AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630492AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00813954029214CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029221CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029238CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029245CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029252CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-30
B454VTP12G10VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-12-21
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-11-21
G517CW2040ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10