FDA.reportPublic FDA data

Mahe Medical USA

Primary DI
00085007823012
Brand
Mahe Medical USA
Company
MAHE MEDICAL USA LLC
Model
1000-00010
Device description
Mios Modified Hohmann Lever Curved Retractor
Published
2025-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085007823012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085007823012000850078230120850078230120085007823012

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8556243633keith@mahemedical.com

Regulatory Flags#

DUNS number
044831540
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850078230041Disruptive MedTechML-11.5x202025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404239MillenniumAvalign Technologies, Inc.GAD2026-07-24
00190776422042MillenniumAvalign Technologies, Inc.GAD2026-07-24
00190776422103MillenniumAvalign Technologies, Inc.GAD2026-07-24
00190776422134MillenniumAvalign Technologies, Inc.GAD2026-07-24
B382SD907394200Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD914172160Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141731000Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141781300Surgical DirectSurgical Direct, Inc.GAD2026-07-24
00190776421977MillenniumAvalign Technologies, Inc.GAD2026-07-23
00198506091926ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506092015ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038600990ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038601250ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018420ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018430ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018840ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039030020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039401000ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601360ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601400ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22