FDA.reportPublic FDA data

Nerve guide, synthetic-polymer, bioabsorbable

Definition
An implantable tubular device constructed of a bio-absorbable synthetic polymer(s) 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 designed 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.
GUDID devices
22
Last updated
2024-08-13 16:50:45

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860012518104allay™ Nerve Cap - Small Nerve SetTulavi Therapeutics, Inc.TL-5515-12024-08-05
00860012518111allay™ Nerve Cap - Large Nerve SetTulavi Therapeutics, Inc.TL-5515-22024-08-05
B454VSC10VersaWrapAlafair Biosciences, Inc.VSC-12024-06-10
08717703990133NeurolacPolyganics Innovations B.V.4,0 mm2015-09-21
08717703990140NeurolacPolyganics Innovations B.V.5,0 mm2015-09-21
08717703990157NeurolacPolyganics Innovations B.V.6.0 mm2015-09-21
08717703990164NeurolacPolyganics Innovations B.V.7.0 mm2015-09-21
08717703990171NeurolacPolyganics Innovations B.V.8.0 mm2015-09-21
08717703990188NeurolacPolyganics Innovations B.V.10.0 mm2015-09-21
08717703990232NEUROCAPPolyganics Innovations B.V.1.5 mm2016-02-02
08717703990249NEUROCAPPolyganics Innovations B.V.2.0 mm2016-02-02
08717703990256NEUROCAPPolyganics Innovations B.V.2.5 mm2016-02-02
08717703990263NEUROCAPPolyganics Innovations B.V.3.0 mm2016-02-02
08717703990270NEUROCAPPolyganics Innovations B.V.4.0 mm2016-02-02
08717703990287NEUROCAPPolyganics Innovations B.V.5.0 mm2016-02-02
08717703990294NEUROCAPPolyganics Innovations B.V.6.0 mm2016-02-02
08717703990300NEUROCAPPolyganics Innovations B.V.7.0 mm2016-02-02
08717703990317NEUROCAPPolyganics Innovations B.V.8.0 mm2016-02-02
08717703990416Neurolac TWPolyganics Innovations B.V.1.5 mm2015-09-21
08717703990423Neurolac TWPolyganics Innovations B.V.2.0 mm2017-07-17
08717703990430Neurolac TWPolyganics Innovations B.V.2.5 mm2017-07-17
08717703990447Neurolac TWPolyganics Innovations B.V.3.0 mm2017-07-17