FDA.reportPublic FDA data

Kerecis® SurgiBind™

Primary DI
05694310961851
Brand
Kerecis® SurgiBind™
Company
KERECIS hf.
Model
3x12 cm
Catalog number
50241S10D0D
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

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
05694310961868PackageGS110In Commercial Distribution
05694310961851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694310961868056943109618685694310961868
05694310961851056943109618515694310961851

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
Length3Centimeter
Width12Centimeter

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

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
05694310961875Kerecis® 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