FDA.reportPublic FDA data

BEAR

Primary DI
G043707700
Brand
BEAR
Company
Bear-Ent, LLC
Model
7.07.70
Catalog number
7.07.70
Device description
Ostium Seeker, Double-Ended, Frontal
Published
2022-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KAKProbe, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043707700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus probeA hand-held manual surgical instrument designed for introduction into the air cavities in the cranial bones which communicate with the nasal cavity (i.e., paranasal sinuses) to explore and/or dilate strictures in the passages from the nose to the communicating sinuses, typically during ear/nose/throat (ENT) surgery. 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
G043615080BEAR6.15.086.15.082026-01-19
G043615090BEAR6.15.096.15.092026-01-19
G043615100BEAR6.15.106.15.102026-01-19
G043617010BEAR6.17.016.17.012022-09-24
G043617020BEAR6.17.026.17.022022-09-24
G043617030BEAR6.17.036.17.032022-09-24
G043617040BEAR6.17.046.17.042022-09-24
G043617050BEAR6.17.056.17.052022-09-24
G043618010BEAR6.18.016.18.012022-07-26
G043615010BEAR6.15.016.15.012022-06-12
G043615020BEAR6.15.026.15.022022-06-12
G043615030BEAR6.15.036.15.032022-06-12
G043615050BEAR6.15.056.15.052022-06-12
G043615060BEAR6.15.066.15.062022-06-12
G043616010BEAR6.16.016.16.012022-06-12
G043616020BEAR6.16.026.16.022022-06-12
G043616030BEAR6.16.036.16.032022-06-12
G043237270BEAR2.37.272.37.272026-08-21
G043111500BEAR1.11.501.11.502026-07-08
G043111510BEAR1.11.511.11.512026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462915071evonosevonos GmbH & Co. KGKAK2026-08-25
04054462915088evonosevonos GmbH & Co. KGKAK2026-08-25
04054462915095evonosevonos GmbH & Co. KGKAK2026-08-25
04054462915101evonosevonos GmbH & Co. KGKAK2026-08-25
04054462905751evonosevonos GmbH & Co. KGKAK2026-08-21
04054462901203evonosevonos GmbH & Co. KGKAK2026-08-18
00840183532963BR Surgical, LLCBR Surgical, LLCKAK2026-07-17
00840183532970BR Surgical, LLCBR Surgical, LLCKAK2026-07-17
00850083275990Intrace USAPILOTIS TECH LLCKAK2026-07-03
09348811115829INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-04-24
09348811005106INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-03-18
00714646001535Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
10714646001532Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
00714646001627Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
09348811115836INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-25
09348811112149INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
09348811150448INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
04250676728609Tube probeSpiggle & Theis Medizintechnik GmbHKAK2025-10-10
04250676731982Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676731999Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732002Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732026Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732033Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740625Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740632Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740649Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740656Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740663Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740687Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740694Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29