FDA.reportPublic FDA data

NeuroShield

Primary DI
07640181711017
Brand
NeuroShield
Company
Monarch Bioimplants GmbH
Model
NS3020
Device description
NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing.
Published
2022-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXICuff, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190246000NeuroShieldMonarch Bioimplants GmbH2019-05-31JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640181711208PackageGS120In Commercial Distribution
07640181711017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640181711208076401817112087640181711208
07640181711017076401817110177640181711017

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, animal-derivedAn implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] 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 intended to 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+41414552121mail@monarchbioimplants.com

Regulatory Flags#

DUNS number
480144102
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640181710010NeuroShieldNS40302022-04-20
07640181711208NeuroShieldNS30202022-09-06
07640181710201NeuroShieldNS40302022-04-20

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