FDA.reportPublic FDA data

SurgiClose® Compact

Primary DI
05694310969567
Brand
SurgiClose® Compact
Company
KERECIS hf.
Model
40 sq cm Compacted Fragmented Fish Skin
Catalog number
50207T105D0D
Device description
Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical 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-compact
Published
2026-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K241080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241080000Kerecis Parvus (50207)Kerecis Limited2024-08-21KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694310969574PackageGS110In Commercial Distribution
05694310969567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694310969574056943109695745694310969574
05694310969567056943109695675694310969567

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
Area/Surface Area0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
7032878752info@kerecis.com

Regulatory Flags#

DUNS number
365732410
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05694310969468MariGen® Compact5 sq cm Compacted Fragmented Fish Skin50207T101B0D2026-09-18
05694310969482MariGen® Compact10 sq cm Compacted Fragmented Fish Skin50207T102B0D2026-09-18
05694310969505MariGen® Compact22 sq cm Compacted Fragmented Fish Skin50207T104B0D2026-09-18
05694310969529MariGen® Compact42 sq cm Compacted Fragmented Fish Skin50207T106B0D2026-09-18
05694310969543SurgiClose® Compact20 sq cm Compacted Fragmented Fish Skin50207T103D0D2026-09-18
05694310969581SurgiClose® Compact64 sq cm Compacted Fragmented Fish Skin50207T107D0D2026-09-18
05694310969604SurgiClose® Compact98 sq cm Compacted Fragmented Fish Skin50207T108D0D2026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632656OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632663OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632670OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632687OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632694OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632700OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31