FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780452829
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
PM-4409
Catalog number
PM-4409
Device description
Integra® Miltex® Miller Bone File, Double-Ended, Reverse Cut
Published
2018-02-26
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
GEOFILE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEOFile, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780452829PrimaryGS10
H834PM44090SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178045282910381780452829

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch
Width5Millimeter
Width5.3Millimeter

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
05010058078598InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058084360InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058178595InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058184367InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058081635InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-05-21
05010058181632InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-05-21
G141514231000Carnegie Surgical LLCCarnegie Surgical LLCGEO2025-02-03
00888912088664DJO SURGICALDJO, LLCGEO2023-09-19
00888912088671DJO SURGICALDJO, LLCGEO2023-09-19
00840319735244Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735251Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735268Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735275Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735282Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735299Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735305Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735312Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735329Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735336Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319701447Hayden MedicalHayden Medical, Inc.GEO2022-07-22
10381780509448Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
H8344028020Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
00888118072481FILEKLS-Martin L.P.GEO2018-09-26
00888118085726FILEKLS-Martin L.P.GEO2018-09-26
10381780409731Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409748Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409755Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409762Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124811Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124861Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02