FDA.reportPublic FDA data

Medfix

Primary DI
00810021830339
Brand
Medfix
Company
MEDFIX INTERNATIONAL, LLC
Model
MF-0438
Device description
Medfix® T-Handle
Published
2020-04-03
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021830339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021830339008100218303398100218303390810021830339

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
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

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