FDA.reportPublic FDA data

Disruptive MedTech

Primary DI
00850078230034
Brand
Disruptive MedTech
Company
MAHE MEDICAL USA LLC
Model
SC-IR TC
Device description
Scissors, Iris Tungsten Carbide
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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078230034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078230034008500782300348500782300340850078230034

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. 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
00850078230041Disruptive MedTechML-11.5x202025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039702SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039719SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039726SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039733SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039740SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039757SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039764SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039771SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
G425050183SCD0My MedicalMy Medical Store LLCLRW2026-05-04
G425050933SC0My MedicalMy Medical Store LLCLRW2026-03-27
09348811003119INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-03-18
09348811000798INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000804INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000842INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000859INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000866INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811153494INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811173058INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
10198956213302CARDINAL HEALTHCardinal Health 200, LLCLRW2025-11-24
09348811000811INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001313INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001702INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811002433INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003171INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003805INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811007117INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
G453CA306140PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-28
G453CA303160PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA331700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA350670PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21