ACELL, INC.

FDA Device Registration & Listing · Columbia, MD, US · Registration 3005920706

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005920706
FEI Number
3005920706
Entity Name
ACELL, INC.
City/State/Country
Columbia, MD, US
Establishment Address
6640 Eli Whitney Dr Ste 200, Columbia, MD 21046, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Integra LifeSciences Corporation (Owner Number: 9004007)
Owner / Operator Contact Address
1100 Campus Rd, Princeton, NJ 08540, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230980
PMA Number
N/A

All Registered Proprietary Names

Medihoney Gel Dressings MicroMatrix Medihoney Cytal® Wound Matrix Cytal® Burn Matrix Gentrix" Surgical Matrix Thick MicroMatrix® UBM Particulate Medihoney Honeycolloid Dressing Gentrix Surgical Matrix Plus Gentrix Surgical Matrix Hiatal Gentrix Surgical Matrix Thin Gentrix Surgical Matrix Cytal Wound Matrix 2-Layer Cytal Burn Matrix Cytal Wound Matrix 3-Layer Cytal Wound Matrix 1-Layer Cytal Wound Matrix 6-Layer Medihoney Dressing with Active Hone Cardion" for Pericardial Repair MicroMatrix Flex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-03-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2021-02-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-03-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-08-20
OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2021-02-26
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2021-02-26
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2021-02-26
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-08-20
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-03-24
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2017-03-24
OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia General, Plastic Surgery Class 2 878.3300 2021-02-26
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2021-02-26
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2021-02-26
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2021-02-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-03-24
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2021-02-26
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2023-09-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integra LifeSciences Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015194982 SURGICAL INNOVATION ASSOCIATES, INC. Chicago, IL, US
3013505638 REBOUND THERAPEUTICS, CORPORATION Irvine, CA, US
3006697299 INTEGRA LIFESCIENCES (IRELAND) LIMITED SRAGH TULLAMORE Offaly, IE
2648988 INTEGRA NEUROSCIENCES ANASCO, PR, US
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071458 Integra LifeSciences Corporation MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K134033 Miromatrix Medical, Inc. MIROMATRIX BIOLOGICAL MESH 2014-03-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
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 3005920706. Last updated year: 2026. Please use registration number 3005920706 when referencing this establishment in official correspondence.
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