Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010894343

FEI Number

3010894343

Entity Name

Reprise Biomedical, Inc.

City/State/Country

Plymouth, MN, US

Establishment Address

17400 Medina Road, Suite 100, Plymouth, MN 55447, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Reprise Biomedical (Owner Number: 10078738)

Owner / Operator Contact Address

17400 Medina Road, Suite 100, Plymouth, MN 55447, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221520

PMA Number

N/A

All Registered Proprietary Names

MiroFlex Biologic Matrix MiroDerm Fenestrated MiroDerm Fenestrated Plus Miro3D Fibers Wound Matrix MiroDry Wound Matrix Miro3D Wound Matrix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2020-11-03
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-11-03
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-04-23
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-03-07
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-11-03

Official Correspondent

Carrie Powers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Reprise Biomedical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010894343. Last updated year: 2026. Please use registration number 3010894343 when referencing this establishment in official correspondence.