FDA.reportPublic FDA data

Kerecis® SurgiBind™

Primary DI
05694310961875
Brand
Kerecis® SurgiBind™
Company
KERECIS hf.
Model
250 sq cm
Catalog number
50241S24D0D
Device description
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
Published
2021-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXHMesh, Surgical, Collagen, Plastic And Reconstructive SurgeryGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202430000Kerecis ReconstructKerecis Limited2021-05-02OXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694310961882PackageGS110In Commercial Distribution
05694310961875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694310961882056943109618825694310961882
05694310961875056943109618755694310961875

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area250Square centimeter

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
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.OXH2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OXH2026-03-24
00812337020671Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXH2025-03-14
00812337020688Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXH2025-03-14
00857072005378MiroFlex®REPRISE BIOMEDICAL, INC.OXH2023-08-04
00857072005392MiroFlex®REPRISE BIOMEDICAL, INC.OXH2023-08-04
00857072005354MiroFlex®REPRISE BIOMEDICAL, INC.OXH2023-05-10
00857072005361MiroFlex®REPRISE BIOMEDICAL, INC.OXH2023-05-10
00857072005385MiroFlex®REPRISE BIOMEDICAL, INC.OXH2023-05-10
00857072005408MiroFlex®REPRISE BIOMEDICAL, INC.OXH2023-05-10
05694310963794Kerecis® SurgiBind™KERECIS hf.OXH2022-09-08
05694310963817Kerecis® SurgiBind™KERECIS hf.OXH2022-09-08
05694310963800Kerecis® Omega3 SurgiBindKERECIS hf.OXH2022-09-08
05694310963824Kerecis® Omega3 SurgiBindKERECIS hf.OXH2022-09-08
05694310961714Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961738Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961752Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961776Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961790Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961813Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961837Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961851Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961899Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961912Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961936Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961950Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961974Kerecis® SurgiBind™KERECIS hf.OXH2021-10-11
05694310961721Kerecis® Omega3 SurgiBindKERECIS hf.OXH2021-10-11
05694310961745Kerecis® Omega3 SurgiBindKERECIS hf.OXH2021-10-11
05694310961769Kerecis® Omega3 SurgiBindKERECIS hf.OXH2021-10-11