FDA.reportPublic FDA data

Mjölnir: Thor's Hammer

Primary DI
00854515008972
Brand
Mjölnir: Thor's Hammer
Company
Unique Surgical
Model
1000 gram
Device description
Whosoever holds this hammer, if he be worthy, shall possess the power of Thor.
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00854515008972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854515008972008545150089728545150089720854515008972

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
818-813-8527info@UniqueSurgical.com

Regulatory Flags#

DUNS number
079820535
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
00850080482063Drill BitBayonet Drill Bit Ø3.2 L152026-01-30
00850080482070Drill BitBayonet Drill Bit Ø3.2 L202026-01-30
00850080482087Drill BitBayonet Drill Bit Ø3.2 L252026-01-30
00850080482094Drill BitBayonet Drill Bit Ø3.2 L302026-01-30
00850080482100Drill BitBayonet Drill Bit Ø3.2 L352026-01-30
00850080482117Drill BitBayonet Drill Bit Ø3.2 L402026-01-30
00850080482124Drill BitBayonet Drill Bit Ø3.2 L452026-01-30
00850080482131Drill BitBayonet Drill Bit Ø3.2 L502026-01-30
00850080482148Drill BitBayonet Drill Bit Ø3.2 L552026-01-30
00850080482155Drill BitBayonet Drill Bit Ø3.2 L602026-01-30
00850080482162Drill BitBayonet Drill Bit Ø3.2 L652026-01-30
00850080482179Drill BitBayonet Drill Bit Ø3.2 L702026-01-30
00850080482186Drill BitBayonet Drill Bit Ø3.2 L752026-01-30
00850080482193Drill BitBayonet Drill Bit Ø3.2 L802026-01-30
00854515008002ImpactorFemoral2023-01-06
00854515008989Medacta Glenosphere Impactor TipCannulated2025-09-16
00854515008927ScrewdriverU-Joint, 3.5mm Hex, Hudson Connector2025-08-07
00854515008934ScrewdriverSolid Shaft, 3.5mm Hex, Hudson Connector2025-08-07
00850080482025Screw ForcepsMedacta, with Cap2025-12-18
00850080482032Bone PinMedacta, Fluted2025-12-18

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Primary DI, Brand, Company table
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00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03