FDA.reportPublic FDA data

BEAR

Primary DI
G043738110
Brand
BEAR
Company
Bear-Ent, LLC
Model
7.38.11
Catalog number
7.38.11
Device description
Wilder Lacrimal Dilator, No.1 (26mm)
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
HNLProbe, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNLProbe, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043738110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal probe, reusableA hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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
00198506090677ELMED INCORPORATEDELMED INCORPORATEDHNL2026-05-12
20757770455953Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00757770460670Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00190776410476MillenniumAvalign Technologies, Inc.HNL2025-09-11
00757770408818Bausch + LombBausch & Lomb IncorporatedHNL2025-08-14
00194613010690MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613010706MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613111731MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
04058935011819Bowman lachrymal probe, 0000-000Bausch & Lomb GmbHHNL2025-07-11
00840343726478GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726485GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726492GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726508GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726515GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726522GEN2SURGIX MEDICAL LLCHNL2025-06-16
G412PH19980MR PHACOCrestpoint Management LimitedHNL2025-06-09
G412PH19600MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19750MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197500MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH1975000MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197510MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197520MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197530MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197540MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19800MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19810MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19820MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19830MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19840MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19850MR PHACOCrestpoint Management LimitedHNL2025-06-07