Home GUDID B089B78531XS001 N/A
Primary DI B089B78531XS001
Brand N/A
Company BLACK & BLACK SURGICAL, INC.
Model B78531-XS
Catalog number B78531-XS
Device description X-SMALL SPECULA, PACK OF 10
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 EPY SPECULUM, ENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EPY Speculum, Ent General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B089B78531XS0 Primary HIBCC 0 B089B78531XS001 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Ear speculum, reusable A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004382282 Device count 10 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840329838454 BLACK & BLACK SURGICAL, INC. B8X-DMER-440-EH ANG B8X-DMER-440-EH ANG 2026-07-30 00840329808884 N/A B65092 B65092 2022-09-21 00840329808891 N/A B65096 B65096 2022-09-21 00840329808907 N/A B65097 B65097 2022-09-21 00840329808914 N/A B65099 B65099 2022-09-21 00840329807306 N/A B62124 B62124 2022-09-21 00840329830397 ASPIRATION TUBING B89205 B89205 2026-07-30 00840329834494 BLACK & BLACK SURGICAL, INC. B89113 B89113 2026-07-30 00840329836856 BLACK & BLACK SURGICAL, INC. B89217 B89217 2026-07-30 00840329837648 ASPIRATION TUBING B89206 B89206 2026-07-30 00840329838409 BLACK & BLACK SURGICAL, INC. B8XBAS-332L-ANG B8XBAS-332L-ANG 2026-07-30 00840329838416 BLACK & BLACK SURGICAL, INC. B8XCC-332L-AH B8XCC-332L-AH 2026-07-30 00840329838430 BLACK & BLACK SURGICAL, INC. B8BX-DMER-632 PWR B8BX-DMER-632 PWR 2026-07-30 00840329838515 BLACK & BLACK SURGICAL, INC. B8XSTD-515-SYR B8XSTD-515-SYR 2026-07-30 00840329800277 N/A B89107 B89107 2022-09-21 00840329800291 N/A B89109 B89109 2022-09-21 00840329838225 BLACK & BLACK SURGICAL, INC. B8XBAS-432BH-AH-RT B8XBAS-432BH-AH-RT 2026-06-08 00840329838232 BLACK & BLACK SURGICAL, INC. B8XIII-332BH-AH-RT B8XIII-332BH-AH-RT 2026-06-08 00840329838249 BLACK & BLACK SURGICAL, INC. B8XIII-432BH-AH-RT B8XIII-432BH-AH-RT 2026-06-08 00840329805982 N/A B61115 B61115 2022-09-21
Other Devices Sharing Product Codes# 
blackandblacksurgical.com