Implantable-device infection control barrier

Definition
A sterile, bioabsorbable, implantable substance intended to be applied as a protective barrier over the surface of an implantable device (e.g., orthopaedic prosthesis) prior to implantation to prevent bacterial adhesion, colonization, and biofilm formation through physical means only; it may be used in conjunction with a separate antimicrobial agent. It contains microbe-derived materials [e.g., hyaluronic acid (HA)] and may be supplied in dry form (e.g., powder) intended to be hydrated prior to use; disposable devices associated with application/preparation (e.g., syringes, adaptors, application nozzle) may be included. This is a single-use device.
GUDID devices
16
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00817169023715Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCBARC2023-01-11
00817169023722Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCBARP2023-01-11
D066PGBARBLK1PlastCareProguard Health, IncPG-BAR-BLK2021-07-02
D066PGBARBLU1PlastCareProguard Health, IncPG-BAR-BLU2021-07-02
D066PGBARCLR1PlastCareProguard Health, IncPG-BAR-CLR2021-07-02
D066PGBARPNK1PlastCareProguard Health, IncPG-BAR-PNK2021-07-02
D066PGBARPUR1PlastCareProguard Health, IncPG-BAR-PUR2021-07-02
00817169023708Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLC12025-12-16
D066PGBARBLK2PlastCareProguard Health, IncPG-BAR-BLK2021-07-02
D066PGBARBLU2PlastCareProguard Health, IncPG-BAR-BLU2021-07-02
D066PGBARCLR2PlastCareProguard Health, IncPG-BAR-CLR2021-07-02
D066PGBARPNK2PlastCareProguard Health, IncPG-BAR-PNK2021-07-02
D066PGBARPUR2PlastCareProguard Health, IncPG-BAR-PUR2021-07-02
D77133353BL1Dental CityICP, INC.33-353BL2021-06-25
D77133353CL1Dental CityICP, INC.33-353CL2021-06-25
D77133353PK1Dental CityICP, INC.33-353PK2021-06-25