FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780463030
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
1-220
Catalog number
1-220
Device description
"Integra® Miltex® Buck Neurological Hammer 7-3/4"", With Brush and Needle, Chrome"
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
GWZPERCUSSOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWZPercussorNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780463030PrimaryGS10
H83412200SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178046303010381780463030

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. 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
00634782101770ADC®AMERICAN DIAGNOSTIC CORPGWZ2026-03-30
00840183526481BR Surgical, LLCBR Surgical, LLCGWZ2024-05-20
00862528000319FluidFloMED SYSTEMS INCGWZ2023-09-05
00840183501389BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183505318BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183506728BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183507343BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183508760BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183519599BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00634782099060ADC®AMERICAN DIAGNOSTIC CORPGWZ2023-01-11
00786511000257Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511075132Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511075149Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511247966Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511247973Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511620257Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511630256Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511870256Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511000240hammer RASHMAN CORPORATIONGWZ2022-12-02
00786511000264Hammer RASHMAN CORPORATIONGWZ2022-12-02
00786511000288Hammer RASHMAN CORPORATIONGWZ2022-12-02
00786511566098HammerRASHMAN CORPORATIONGWZ2022-12-02
00786511788346HammerRASHMAN CORPORATIONGWZ2022-12-02
00786511787585Prestige MedicalRASHMAN CORPORATIONGWZ2020-10-08
04046826046101MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046118MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046262MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046057MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046071MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24