FDA.reportPublic FDA data

Disruptive MedTech

Primary DI
00850078230041
Brand
Disruptive MedTech
Company
MAHE MEDICAL USA LLC
Model
ML-11.5x20
Device description
Mallet, 11.5x20mm head, 432g
Published
2025-08-14
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
HXLMallet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078230041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078230041008500782300418500782300410850078230041

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
8556243633complaints@mahemedical.com

Regulatory Flags#

DUNS number
044831540
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085007823012Mahe Medical USA1000-000102025-08-28
00850078230164Mahe Medical USAU-ESR-AS1-AO-S2025-09-12
00850078230171Mahe Medical USAU-ESR-AS2-AO-S2025-09-12
00850078230188Mahe Medical USAU-ESR-AS3-AO-S 2025-09-12
00850078230195Mahe Medical USAU-ESR-AS4-AO-S2025-09-12
00850078230201Mahe Medical USAU-ESR-AS5-AO-S 2025-09-12
00850078230218Mahe Medical USAU-ESR-AS6-AO-S 2025-09-12
00850078230225Mahe Medical USAU-ESR-KS1-AO-S2025-09-12
00850078230232Mahe Medical USAU-ESR-KS2-AO-S2025-09-12
00850078230249Mahe Medical USAU-ESR-KS3-AO-S 2025-09-12
00850078230256Mahe Medical USAU-ESR-KS4-AO-S 2025-09-12
00850078230263Mahe Medical USAU-ESR-KS5-AO-S 2025-09-12
00850078230270Mahe Medical USAU-ESR-KS6-AO-S2025-09-12
00850078230133Mahe Medical USA1000-000502025-08-28
00850078230140Mahe Medical USA1000-000252025-08-28
00850078230157Mahe Medical USA1000-000752025-08-28
00850078230003Disruptive MedTechCUR-4.5 Ring2025-08-14
00850078230010Disruptive MedTechCUR-6.0 Ring2025-08-14
00850078230027Disruptive MedTechFOR-AD-NT2025-08-14
00850078230034Disruptive MedTechSC-IR TC2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817493028257Hive Standalone Cervical SystemNanohive Medical LLCHXL2026-05-08
00840311245635Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXL2026-03-18
00810158218871PRINCETONPrinceton Medical Group, Inc.HXL2026-02-16
B382SD9145561170Surgical DirectSurgical Direct, Inc.HXL2026-02-16
B382SD9141061010Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145561160Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD914556300Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145970180Surgical DirectSurgical Direct, Inc.HXL2026-02-09
03662663083683ActivLHighridge Medical, LLCHXL2026-02-03
00840180545829General InstrumentsALPHATEC SPINE, INC.HXL2026-01-29
00810158218482PRINCETONPrinceton Medical Group, Inc.HXL2026-01-15
00841731135322Redemption VILEX LLCHXL2026-01-12
03662663154543SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663154581SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663155601Zyston Interbody Spacer SystemHighridge Medical, LLCHXL2025-12-29
00840194418157PediflexORTHOPEDIATRICS CORP.HXL2025-12-11
03662663217002Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHXL2025-11-17
03662663267199Timberline Lateral Fusion SystemHighridge Medical, LLCHXL2025-11-16
00887868294976TM Ardis Interbody SystemHighridge Medical, LLCHXL2025-11-14
03662663129831Disc Preparation InstrumentsHighridge Medical, LLCHXL2025-11-14
03662663109239Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHXL2025-11-12
03662663109703Mergence-A Preparation InstrumentationHighridge Medical, LLCHXL2025-11-12
00810074308748250mm MalletOsteocentric Technologies, Inc.HXL2025-10-21
00810135963657ImpactNVISION BIOMEDICAL TECHNOLOGIES, INC.HXL2025-09-24
00810189110526MALLETOsteocentric Technologies, Inc.HXL2025-09-22
B382SD914554370Surgical DirectSurgical Direct, Inc.HXL2025-09-12
B382SD91455610310Surgical DirectSurgical Direct, Inc.HXL2025-09-12
00840314269812gSourceGSOURCE LLCHXL2025-08-29
00757770423750Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08
00757770428953Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08