FDA.reportPublic FDA data

Kerecis® SurgiClose® Silicone

Primary DI
05694310965385
Brand
Kerecis® SurgiClose® Silicone
Company
KERECIS hf.
Model
3 x 3 cm fish skin
Catalog number
50214F57D0D
Device description
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
Published
2025-08-20
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
K213231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213231000Kerecis SiliconeKerecis Limited2022-06-29KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694310965392PackageGS110In Commercial Distribution
05694310965385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694310965392056943109653925694310965392
05694310965385056943109653855694310965385

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
Height3Centimeter
Width3Centimeter

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
05694310965347Kerecis® MariGen®Expanse cm 6 x 6 / Meshed 3:150200O46B0D2025-08-29
05694310965361Kerecis® GraftGuide®300 sq cm Meshed 3:150202O23D0D2025-08-29

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