FDA.reportPublic FDA data

Wheelhouse Medical Specials

Primary DI
00850058050041
Brand
Wheelhouse Medical Specials
Company
Wheelhouse Medical
Model
WM01-0072-014
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
00850058050041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058050041008500580500418500580500410850058050041

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
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
00850058050133Wheelhouse Medical SpecialsWM01-01202024-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085552neon3Ulrich GmbH & Co. KGLXH2026-05-28
M7403030028Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030029Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522823Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522830Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522847Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522861Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00889929072424Matrixx SystemNEXXT SPINE, LLCLXH2026-05-27
07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25