FDA.report

Medfix

Primary DI
00810021830827
Brand
Medfix
Company
MEDFIX INTERNATIONAL, LLC
Model
MF-18100TB
Device description
Medfix® TRS Beveled Retractor Tube, 18mm Dia. x 100mm, Blue
Published
2019-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTXRONGEUR
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810021830827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021830827008100218308278100218308270810021830827

GMDN Terms

TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(520)398-5467sales@medfix.com

Regulatory Flags

DUNS number
079699357
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850061673459MedfixMF-0113S2025-03-14
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
00850061673145MedfixMF110-1899-INSERT2025-03-05
00850061673152MedfixMF-2345FL2025-03-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810220800171Adler Instrument CompanyAdler, Inc.MDM2026-05-26
00810220800188Adler Instrument CompanyAdler, Inc.MDM2026-05-26
00810055250189Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810055250202Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450509Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450516Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450547Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450554Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450561Surgical DesignSurgical Design, Inc.HTX2026-05-23
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00810189450585Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450592Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450608Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450615Surgical DesignSurgical Design, Inc.HTX2026-05-23
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00810189450639Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450646Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450653Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450660Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451322Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451339Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451346Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451353Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451360Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451377Surgical DesignSurgical Design, Inc.HTX2026-05-23
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00810189451407Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451414Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451520Surgical DesignSurgical Design, Inc.HTX2026-05-23