FDA.reportPublic FDA data

Medfix

Primary DI
00850061673459
Brand
Medfix
Company
MEDFIX INTERNATIONAL, LLC
Model
MF-0113S
Device description
Medfix® CS Transverse Retractor
Published
2025-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850061673459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061673459008500616734598500616734590850061673459

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(520)398-5467sales@medfix.com

Regulatory Flags#

DUNS number
079699357
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021836997MedfixMF-70022020-04-03
00810021831084MedfixMF15-23092020-04-03
00810021830872MedfixMF14-23092020-04-03
00850061673350MedfixMF229-50522025-03-06
00850061673367MedfixMF229-50472025-03-06
00850061673374MedfixMF229-50372025-03-06
00850061673008MedfixMF-EC812025-03-05
00850061673015MedfixMF-EC822025-03-05
00850061673022MedfixMF-EC832025-03-05
00850061673039MedfixMF-EC842025-03-05
00850061673046MedfixMF-EC852025-03-05
00850061673053MedfixMF-201202025-03-05
00850061673060MedfixMF-271202025-03-05
00850061673077MedfixMF-75032025-03-05
00850061673084MedfixMF237-8201T2025-03-05
00850061673091MedfixMF-EC1152025-03-05
00850061673107MedfixMF-EC1142025-03-05
00850061673114MedfixMF-EC1132025-03-05
00850061673121MedfixMF-EC1122025-03-05
00850061673138MedfixMF-EC1112025-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434144MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434205MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434212MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434601MillenniumAvalign Technologies, Inc.GAD2026-10-09
00198506095849ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00198506095856ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00840277133717Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133922Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133939Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133946Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133953Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133960Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133977Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133984Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133991Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277134004Innomed, Inc.INNOMED, INC.GAD2026-10-09
00190776433826MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433833MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433871MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776434014MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776436285MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433628MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433642MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433659MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433741MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776434526MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776436179MillenniumAvalign Technologies, Inc.GAD2026-10-07
G141518123170Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G141518861000Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G141572107210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07