FDA.reportPublic FDA data

Wheelhouse Medical Specials

Primary DI
00850058050126
Brand
Wheelhouse Medical Specials
Company
Wheelhouse Medical
Model
WM01-0118
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
00850058050126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058050126008500580501268500580501260850058050126

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft inserter, reusableA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. 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
00850058050133Wheelhouse Medical SpecialsWM01-01202024-10-23

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Primary DI, Brand, Company table
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00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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