FDA.reportPublic FDA data

Kerecis® MariGen®

Primary DI
05694310965347
Brand
Kerecis® MariGen®
Company
KERECIS hf.
Model
Expanse cm 6 x 6 / Meshed 3:1
Catalog number
50200O46B0D
Device description
Fish-skin graft for wound management. Kerecis® MariGen® is indicated for the management of wounds including: Partial-thickness wounds (extending through the epidermis or into dermis), Full-thickness wounds (extending through the dermis to deeper tissues such as subcutaneous fat, muscle, tendon or bone), pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds.IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
Published
2025-08-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132343000MARIGEN WOUND DRESSINGKerecis Limited2013-10-23KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694310965354PackageGS110In Commercial Distribution
05694310965347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694310965354056943109653545694310965354
05694310965347056943109653475694310965347

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Centimeter
Width6Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
7032878752info@kerecis.com

Regulatory Flags#

DUNS number
365732410
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05694310968560Kerecis SurgiClose® Silicone20 x 30 cm fish skin Fenestrated50214F61D0D2026-04-22
05694310968584Kerecis GraftGuide® Silicone20 x 30 cm fish skin Punched50213U61D0D2026-04-22
05694310966443Kerecis SurgiBind® Tendon Protect 3 x 5 cm 50242S70D0D2026-02-03
05694310966474Kerecis SurgiBind® Tendon Protect 6 x 9 cm 50242S71D0D2026-02-03
05694310966467Kerecis SurgiBind® Tendon Protect 3 x 5 cm 50242S70D0D2026-02-03
05694310966450Kerecis SurgiBind® Tendon Protect 6 x 9 cm 50242S71D0D2026-02-03
05694310967990Kerecis MariGen® 3 x 3.26 cm Fenestrated50200F72B0D2026-01-30
05694310968010Kerecis MariGen®4 x 5 cm Fenestrated50200F73B0D2026-01-30
05694310968034Kerecis MariGen®6 x 7 cm Fenestrated50200F74B0D2026-01-30
05694310968058Kerecis MariGen®5 x 11 cm Fenestrated50200F75B0D2026-01-30
05694310968072Kerecis MariGen®5 x 14 cm Fenestrated50200F76B0D2026-01-30
05694310968096Kerecis MariGen®5 x 14 cm Meshed 2:150200N76B0D2026-01-30
05694310968003Kerecis MariGen® 3 x 3.26 cm Fenestrated50200F72B0D2026-01-30
05694310968027Kerecis MariGen®4 x 5 cm Fenestrated50200F73B0D2026-01-30
05694310968041Kerecis MariGen®6 x 7 cm Fenestrated50200F74B0D2026-01-30
05694310968065Kerecis MariGen®5 x 11 cm Fenestrated50200F75B0D2026-01-30
05694310968089Kerecis MariGen®5 x 14 cm Fenestrated50200F76B0D2026-01-30
05694310968102Kerecis MariGen®5 x 14 cm Meshed 2:150200N76B0D2026-01-30
05694310965361Kerecis® GraftGuide®300 sq cm Meshed 3:150202O23D0D2025-08-29
05694310965354Kerecis® MariGen®Expanse cm 6 x 6 / Meshed 3:150200O46B0D2025-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028385collateneCOLLAGEN MATRIX, INC.KGN2026-05-05
10840330705858ProCureTwin Med, LLCKGN2026-05-04
10840330705834ProCureTwin Med, LLCKGN2026-04-28
10840330705841ProCureTwin Med, LLCKGN2026-04-28
00812593023119NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023072NeoSurg Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023089ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31
16942327004853DimoraWinner Medical Co., Ltd.KGN2026-03-30
16942327019628DimoraWinner Medical Co., Ltd.KGN2026-03-30
16942327050027DimoraWinner Medical Co., Ltd.KGN2026-03-30
00813954028736SALVIN OraCOTE+COLLAGEN MATRIX, INC.KGN2026-03-18
00813954028743SALVIN OraPLUG+COLLAGEN MATRIX, INC.KGN2026-03-18
00813954028750SALVIN OraTAPE+COLLAGEN MATRIX, INC.KGN2026-03-18
10888277720725MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
10888277720732MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
00813954028439Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.KGN2026-03-09
00813954028446Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.KGN2026-03-09
00813954028545bioSTRIPCOLLAGEN MATRIX, INC.KGN2026-03-09