FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780463771
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-102
Catalog number
19-102
Device description
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-128 Vibrations
Published
2018-03-22
Public version status
Update
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
10381780463771PrimaryGS10
H834191020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178046377110381780463771

GMDN Terms#

Term, Definition table
TermDefinition
Tuning fork"A 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
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

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
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