FDA.reportPublic FDA data

Disruptive MedTech

Primary DI
00850078230027
Brand
Disruptive MedTech
Company
MAHE MEDICAL USA LLC
Model
FOR-AD-NT
Device description
Foreceps, Adson Toothless
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078230027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078230027008500782300278500782300270850078230027

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
00850078230034Disruptive MedTechSC-IR TC2025-08-14
00850078230041Disruptive MedTechML-11.5x202025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431006MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776431013MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04
00190776429058MillenniumAvalign Technologies, Inc.GEN2026-09-04
04058749001280NAFehling Instruments GmbH & Co. KGGEN2026-09-04
00190776427993MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776428167MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776427559MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427665MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427740MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427764MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427771MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427788MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427795MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776420369MillenniumAvalign Technologies, Inc.GEN2026-08-25
00190776418236MillenniumAvalign Technologies, Inc.GEN2026-08-23
00190776427238MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427269MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427276MillenniumAvalign Technologies, Inc.GEN2026-08-21
B382SD914775290Surgical DirectSurgical Direct, Inc.GEN2026-08-21
00190776417727MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776426767MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776417109MillenniumAvalign Technologies, Inc.GEN2026-08-18
00198506094002ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00198506094057ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00190776425838MillenniumAvalign Technologies, Inc.GEN2026-08-17
G453333630140PEAK MEDICALPeak Medical Distribution Inc.GEN2026-08-14
00190776423544MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776423735MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776424404MillenniumAvalign Technologies, Inc.GEN2026-08-07