FDA.reportPublic FDA data

Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade Kit

Primary DI
00860011177814
Brand
Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade Kit
Company
MAP MEDICAL SOLUTIONS, LLC
Model
AB0225
Device description
Hip Stem Extractor Guide Block Assembly, Adjustable Back Pressure Blade, Adjustable Back Pressure Blade Screw, Adjustable Back Pressure Blade Screw Locking Washer, Back Pressure Blade Support, Conical Trunnion Adapter (Small), Conical Trunnion Adapter (Large), Conical Trunnion Adapter Nut, Rigid Medial Calcar Blade, Anterior & Posterior Osteotome, Anterior & Posterior Osteotome, Universal Blade, Rigid Lateral Blade, Flexible Medial Calcar Blade, Flexible Lateral Blade
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
00860011177814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011177814008600111778148600111778140860011177814

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(208) 203-8064info@mapmedicalsolutions.com

Regulatory Flags#

DUNS number
109500577
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011177821Wright-Out Hip Stem Extractor Tool KitAB02202026-07-06
00860011177838Wright-Out Hip Stem Extractor Slide HammerAB02152026-07-06
00860011177845Wright-Out Hip Stem Extractor Osteotome HandleAB02102026-07-06
00860011177852Wright-Out Hip Stem Extractor 5/64" T-Handle Hex KeyAB02052026-07-06
00860011177869Wright-Out Hip Stem Extractor 10mm T-Handle Socket WrenchAB02002026-07-06

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