Home GUDID 00827002314559
Biodesign
Primary DI 00827002314559
Brand Biodesign
Company COOK BIOTECH INCORPORATED
Model G31455
Catalog number C-PHR-7X10-U
Device description Biodesign Hiatal Hernia Graft
Published 2015-11-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name OWV Mesh, surgical, collagen, diaphragmatic hernia
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10827002314556 Package GS1 1 In Commercial Distribution 00827002314559 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10827002314556 10827002314556 00827002314559 00827002314559 827002314559 0827002314559
GMDN Terms# Term, Definition table Term Definition Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial A 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
Regulatory Flags# DUNS number 945385862 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 false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00085412818313 Supple Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818375 Supple Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818405 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818429 Supple Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818443 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818597 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818610 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818658 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818672 Supple Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00085412818696 Supple Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2023-05-15 00386190001592 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001844 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001851 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001868 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001875 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001882 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001899 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001905 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001912 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001929 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001936 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001943 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001950 Gentrix® ACELL, INC. OWV 2019-02-15 00386190001967 Gentrix® ACELL, INC. OWV 2019-02-15 10827002565804 Biodesign COOK BIOTECH INCORPORATED OWV 2015-11-03 00827002515789 Biodesign COOK BIOTECH INCORPORATED OWV 2015-11-03 00085412530529 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2015-10-08 00085412530567 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2015-10-08 00085412530581 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2015-10-08 00085412530604 Peri-Guard SYNOVIS LIFE TECHNOLOGIES, INC. OWV 2015-10-08