FDA.report

Medfix

Primary DI
00810021837611
Brand
Medfix
Company
MEDFIX INTERNATIONAL, LLC
Model
MF750-3014
Device description
Medfix® TX Double-Bit 15.0/20.0mm
Published
2020-04-03
Public version status
New
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810021837611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021837611008100218376118100218376110810021837611

GMDN Terms

TermDefinition
Screw extractor, reusableA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. 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

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