FDA.reportPublic FDA data

BEAR

Primary DI
G043630240
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.30.24
Catalog number
6.30.24
Device description
Hartmann Tuning Fork, SS, C-128
Published
2024-10-29
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
GWXFork, Tuning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWXFork, TuningNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043630240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tuning forkA hand-held, mechanical test instrument designed as an acoustic resonator used to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. It is usually made of stainless steel in the form of a two-pronged fork with the prongs (tines) formed from a U-shaped bar with a handle attached at the base of the "U". It resonates at a specific constant pitch when set vibrating by striking it against a surface or with an object. The pitch that a particular tuning fork generates depends on the length of the two prongs. 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
00190776423810MillenniumAvalign Technologies, Inc.GWX2026-08-26
04054462902200evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902224evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902231evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902248evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902262evonosevonos GmbH & Co. KGGWX2026-08-18
00810055255115Surgical DesignSurgical Design, Inc.GWX2026-05-17
09348811149084INKAThe Trustee for KAISER FAMILY TRUSTGWX2025-11-26
09348811110060INKAThe Trustee for KAISER FAMILY TRUSTGWX2025-11-21
00190776398231MillenniumAvalign Technologies, Inc.GWX2025-05-19
04049047025443GimmiGimmi GmbHGWX2025-05-06
00757770411702Bausch + LombBausch & Lomb IncorporatedGWX2024-12-23
G043630250BEARBear-Ent, LLCGWX2024-10-29
G043630270BEARBear-Ent, LLCGWX2024-10-29
00887482116593Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116609Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116616Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116623Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116630Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-15
00887482103906Symmetry JannettaASPEN SURGICAL PRODUCTS, INC.GWX2024-08-02
00887482103913Symmetry JannettaASPEN SURGICAL PRODUCTS, INC.GWX2024-08-02
04049197305662RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305679RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305686RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305709RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305747RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305808RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305815RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305822RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28