Home GUDID B089B675600 N/A
Primary DI B089B675600
Brand N/A
Company BLACK & BLACK SURGICAL, INC.
Model B67560
Catalog number B67560
Device description AUTOCLAVABLE EYE PROTECTION SHIELD W/SILICONE SUCTION CUP, PEDIATRIC, 18X14MM, WHITE OPAQUE, NON-STERILE
Published 2022-09-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HQH EYE, ARTIFICIAL, NON-CUSTOM
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HQH Eye, Artificial, Non-Custom Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B089B675600 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Radiation/mechanical corneal shield, reusable A protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004382282 Device count 1 DM exempt true 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 true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published PROSV2623 Soper Brothers Custom Soper Brothers, Incorporated HQH 2026-03-03 SHELLV2627 Soper Brothers Custom Soper Brothers, Incorporated HQH 2026-03-03 G568V2623 Artificial Eye, Plastic, Custom THOMPSON OCULAR PROSTHETICS, INC. HQH 2025-03-10 B796V2623 Eye, Artificial, Non-Custom MIDWEST EYE LABORATORIES, INC. HQH 2024-03-27 G6011000 Sil-Ophtho SIL-OPHTHO, LLC HQH 2024-03-14 G601100T0 Sil-Ophtho SIL-OPHTHO, LLC HQH 2024-03-14 G6013500 Sil-Ophtho SIL-OPHTHO, LLC HQH 2024-03-14 G601350T0 Sil-Ophtho SIL-OPHTHO, LLC HQH 2024-03-14 G519V2623 Eye, Artificial, Non-Custom Midwest Eye Laboratories Sioux Falls, LLC HQH 2024-03-10 G290V2623 Eye, Artificial, Non-Custom Midwest Eye Laboratories Woodbury, LLC HQH 2024-02-19 G542V26230 Artificial Eye THE EYE CONCERN, INC. HQH 2024-01-10 G521V2623 Artificial Eye, Plastic, Custom Legrand Associates HQH 2023-10-18 00840329810528 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810535 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810542 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810559 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810566 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810573 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810580 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810597 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 00840329810603 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-21 B089B675610 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B089B675620 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B089B675630 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B089B675650 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B089B675660 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B089B675670 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B089B675680 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B089B675690 N/A BLACK & BLACK SURGICAL, INC. HQH 2022-09-12 B863E661087V2623 Artificial Eye, Plastic, Custom TEXAS EYE PROSTHETICS LLC HQH 2020-04-14
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