FDA.reportPublic FDA data

Wheelhouse Medical Specials

Primary DI
00860009952447
Brand
Wheelhouse Medical Specials
Company
Wheelhouse Medical
Model
WM01-0066
Published
2024-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00860009952447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009952447008600099524478600099524470860009952447

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7049629429johnsouza@wheelhouse-medical.com

Regulatory Flags#

DUNS number
118496839
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
00850058050157Wheelhouse Medical SpecialsWM01-01412025-10-08
00850058050164Wheelhouse Medical SpecialsWM01-01422025-10-08
00850058050188Wheelhouse Medical SpecialsWM01-01442025-10-08
00850058050225Wheelhouse Medical SpecialsWM01-01482025-10-08
00850058050256Wheelhouse Medical SpecialsWM01-01532025-10-08
00850058050263Wheelhouse Medical SpecialsWM01-01732025-10-08
00850058050287Wheelhouse Medical SpecialsWM01-01572025-10-08
00850058050003Wheelhouse Medical SpecialsWM01-0072-0102024-10-23
00850058050010Wheelhouse Medical SpecialsWM01-0072-0112024-10-23
00850058050027Wheelhouse Medical SpecialsWM01-0072-0122024-10-23
00850058050034Wheelhouse Medical SpecialsWM01-0072-0132024-10-23
00850058050041Wheelhouse Medical SpecialsWM01-0072-0142024-10-23
00850058050058Wheelhouse Medical SpecialsWM01-0072-0152024-10-23
00850058050065Wheelhouse Medical SpecialsWM01-00852024-10-23
00850058050072Wheelhouse Medical SpecialsWM01-00862024-10-23
00850058050089Wheelhouse Medical SpecialsWM01-00782024-10-23
00850058050096Wheelhouse Medical SpecialsWM01-00792024-10-23
00850058050102Wheelhouse Medical SpecialsWM01-01122024-10-23
00850058050119Wheelhouse Medical SpecialsWM01-01172024-10-23
00850058050126Wheelhouse Medical SpecialsWM01-01182024-10-23

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