FDA.reportPublic FDA data

GEN2

Primary DI
00840343719388
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2E901117
Catalog number
G2E901117
Device description
TUNING FORK C512, W/OUT WEIGHTS
Published
2024-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00840343719388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343719388008403437193888403437193880840343719388

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

Contacts#

Phone, Email table
PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags#

DUNS number
080402644
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
00840343727437Gen2G2N99753G2N997532026-04-23
00840343727567Gen2G2G37293G2G372932026-04-23
00840343727574Gen2G2N99755G2N997552026-04-23
00840343727581Gen2G2C62489G2C624892026-04-23
00840343727451Gen2G2N49254G2N492542026-04-22
00840343727468Gen2G2G37278G2G372782026-04-22
00840343727475Gen2G2G37279G2G372792026-04-22
00840343727482Gen2G2G35954G2G359542026-04-22
00840343727499Gen2G2C62277G2C622772026-04-22
00840343727505Gen2G2C62434G2C624342026-04-22
00840343727512Gen2G2N48672TCG2N48672TC2026-04-22
00840343727529Gen2G2N87457G2N874572026-04-22
00840343727536Gen2G2N99517G2N995172026-04-22
00840343727543Gen2G2G37282G2G372822026-04-22
00840343727550Gen2G2O917144G2O9171442026-04-22
00840343727291GEN2G2E901343G2E9013432026-04-16
00840343727307GEN2G2E901344G2E9013442026-04-16
00840343727314GEN2G2E901345G2E9013452026-04-16
00840343727321GEN2G2E900935G2E9009352026-04-16
00840343727338GEN2G2N52380G2N523802026-04-16

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
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
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