FDA.reportPublic FDA data

Mahe Medical USA

Primary DI
00850078230140
Brand
Mahe Medical USA
Company
MAHE MEDICAL USA LLC
Model
1000-00025
Device description
Ranawat Retractor Right
Published
2025-08-28
Public version status
New
Distribution status
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
00850078230140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078230140008500782301408500782301400850078230140

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
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
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
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00810143904659SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904680SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904697SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904703SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904710SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904727SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904918SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904925SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904932SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904956SURGIPROSSurgipros, LLCGAD2026-07-30
00810143905045SURGIPROSSurgipros, LLCGAD2026-07-30