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
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

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