FDA.reportPublic FDA data

Kerecis® Omega3 SurgiBind

Primary DI
05694310961981
Brand
Kerecis® Omega3 SurgiBind
Company
KERECIS hf.
Model
300cm2 Fenestrated SurgiBind
Catalog number
50241G23D0D
Device description
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 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. https://www.kerecis.com/wp-content/uploads/2021/10/KM-21-0117v2-IFU-Kerecis-SurgiBind.pdf
Published
2021-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
05694310961981PackageGS110In Commercial Distribution
05694310961974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694310961981056943109619815694310961981
05694310961974056943109619745694310961974

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area300Square 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

Sterilization Methods#

Method table
Method

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
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
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