FDA.reportPublic FDA data

BEAR

Primary DI
G043200620
Brand
BEAR
Company
Bear-Ent, LLC
Model
2.00.62
Catalog number
2.00.62
Device description
Swiss Jeweler's Forceps w 0.30mm Tips, No.2
Published
2022-08-03
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
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043200620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.

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
04059453116635Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNR2026-08-25
00190776426576MillenniumAvalign Technologies, Inc.HNR2026-08-19
00190776426774MillenniumAvalign Technologies, Inc.HNR2026-08-19
00198506093975ELMED INCORPORATEDELMED INCORPORATEDHNR2026-08-18
G346EA41HSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-08-14
00190776411480MillenniumAvalign Technologies, Inc.HNR2026-08-07
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNR2026-08-07
B382SD9028531640Surgical DirectSurgical Direct, Inc.HNR2026-08-07
G22312552000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-08-03
00840319759202Hayden MedicalHayden Medical, Inc.HNR2026-07-30
G2231114060Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G2231119000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G223111901T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G22312408910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
00190776405854MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776405878MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776398675MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403690MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403737MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776398668MillenniumAvalign Technologies, Inc.HNR2026-07-16
00190776398699MillenniumAvalign Technologies, Inc.HNR2026-07-16
00860015282002Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282019Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282026Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282033Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282071Intrace USAPILOTIS TECH LLCHNR2026-07-03
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17
G006D5011895010COLIBRI FORCEP 0.12 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13