Home GUDID D066PGBARBLK2 PlastCare
Primary DI D066PGBARBLK2
Brand PlastCare
Company Proguard Health, Inc
Model PG-BAR-BLK
Catalog number PG-BAR-BLK
Device description Barrier Film Black
Published 2021-07-02
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name IWX Barrier, Control Panel, X-Ray, Movable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IWX Barrier, Control Panel, X-Ray, Movable Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D066PGBARBLK2 Package HIBCC 8 In Commercial Distribution D066PGBARBLK1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Implantable-device infection control barrier 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.
Regulatory Flags# DUNS number 129529337 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false 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 00814907020548 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-14 00814907020340 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020562 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020579 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020593 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020609 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020623 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020647 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020654 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020661 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-12 00814907020425 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-11 00814907020432 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-11 00814907020463 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-11 00814907020500 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-11 00814907020555 ScatPad CARDIO-MEDICAL PRODUCTS, INC. IWX 2024-09-11 00811870037788 Manus Medical, LLC Manus Medical, LLC IWX 2023-11-08 G242LPSGS24249 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPSGS24369 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPSGS24489 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPSH36369 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPSH48489 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPSS24249 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPSS24369 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPSS24489 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPST2424S9 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPST2430S9 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPST2436S9 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPST2448S9 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPST3030S9 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20 G242LPST3036S9 Techno-Aide Techno-Aide, Inc. IWX 2023-10-20