FDA.reportPublic FDA data

BEAR

Primary DI
G043630270
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.30.27
Catalog number
6.30.27
Device description
Hartmann Tuning Fork, SS, C-1024
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
G043630270PrimaryHIBCC0

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
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
G043200650BEAR2.00.652.00.652022-08-03
G043200660BEAR2.00.662.00.662022-08-03
G043200670BEAR2.00.672.00.672022-08-03
G043200680BEAR2.00.682.00.682022-08-03
G043MLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2022-05-19
G043MLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2022-05-19
G043MLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2022-05-19
G043MLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2022-05-19
G043MLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2022-05-19
G043MLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2022-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G043630240BEARBear-Ent, LLCGWX2024-10-29
G043630250BEARBear-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
04049197305839RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305860RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305884RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305938RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305969RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305976RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28