FDA.reportPublic FDA data

BEAR

Primary DI
G043607170
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.07.17
Catalog number
6.07.17
Device description
Bruenings Ear Specula Rack
Published
2023-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043607170PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123551586
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G043111500BEAR1.11.501.11.502026-07-08
G043111510BEAR1.11.511.11.512026-07-08
G043111520BEAR1.11.521.11.522026-07-08
G043111540BEAR1.11.541.11.542026-07-08
G043111550BEAR1.11.551.11.552026-07-08
G043111560BEAR1.11.561.11.562026-07-08
G043111570BEAR1.11.571.11.572026-07-08
G043111580BEAR1.11.581.11.582026-07-08
G043111590BEAR1.11.591.11.592026-07-08
G043111600BEAR1.11.601.11.602026-07-08
G04320061G0GEIZ2.00.61.G2.00.61.G2026-05-26
G04320062G0GEIZ2.00.62.G2.00.62.G2026-05-26
G04320065G0GEIZ2.00.65.G2.00.65.G2026-05-26
G04320067G0GEIZ2.00.67.G2.00.67.G2026-05-26
G04320068G0GEIZ2.00.68.G2.00.68.G2026-05-26
G043200600BEAR2.00.602.00.602022-08-03
G043200610BEAR2.00.612.00.612022-08-03
G043200620BEAR2.00.622.00.622022-08-03
G043200630BEAR2.00.632.00.632022-08-03
G043200640BEAR2.00.642.00.642022-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809991035006Shim SPOTDOCTORSHIM KOREA INC.EPY2026-07-10
00850083275808Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275815Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275877Intrace USAPILOTIS TECH LLCEPY2026-07-03
00810158216594PRINCETONPrinceton Medical Group, Inc.EPY2026-06-23
00810189451704Surgical DesignSurgical Design, Inc.EPY2026-06-10
09348811148858INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148889INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148957INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148919INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
09348811148933INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
G043714000BEARBear-Ent, LLCEPY2026-05-07
G04371401G0GEIZBear-Ent, LLCEPY2026-05-07
G04371402G0GEIZBear-Ent, LLCEPY2026-05-07
G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
04250407704490FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704766FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704780FENTEXFENTEX medical GmbHEPY2022-12-07