FDA.reportPublic FDA data

Wright-Out Hip Stem Extractor Tool Kit

Primary DI
00860011177821
Brand
Wright-Out Hip Stem Extractor Tool Kit
Company
MAP MEDICAL SOLUTIONS, LLC
Model
AB0220
Device description
Hip Stem Extractor Tools: Slide Hammer, Osteotome Handle, 5/64" T-Handle Hex Key, 10mm T-Handle Socket Wrench
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
false
Single use
false

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011177821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011177821008600111778218600111778210860011177821

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
109500577
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011177814Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade KitAB02252026-07-06
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