FDA.report

Surgical Direct

Primary DI
B382SD914546100
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91454610
Catalog number
SD91454610
Device description
12" Orthopedic Mallet, 5 lb
Published
2023-06-08
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

Related Records

Contact Domains

Product Codes

CodeName
HXLMallet

Product Code Classifications

CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SD914546100PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(386) 738-1202info@surgicaldirect.com

Regulatory Flags

DUNS number
124367223
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
B382S1350010Surgical DirectS1350.01S1350.012026-03-09
B382S18382020Surgical DirectS1838.202S1838.2022026-03-09
B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
B382S18382050Surgical DirectS1838.205S1838.2052026-03-09
B382S18382060Surgical DirectS1838.206S1838.2062026-03-09
B382S18382100Surgical DirectS1838.210S1838.2102026-03-09
B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
B382S2511200Surgical DirectS2511.20S2511.202026-03-09
B382S2548010Surgical DirectS2548.01S2548.012026-03-09
B382S2548020Surgical DirectS2548.02S2548.022026-03-09
B382S2871200Surgical DirectS2871.20S2871.202026-03-09
B382S344901020Surgical DirectS34490.102S34490.1022026-03-09
B382S3797050Surgical DirectS3797.05S3797.052026-03-09
B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

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B382SD9141061010Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145561160Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD914556300Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145970180Surgical DirectSurgical Direct, Inc.HXL2026-02-09
03662663083683ActivLHighridge Medical, LLCHXL2026-02-03
00840180545829General InstrumentsALPHATEC SPINE, INC.HXL2026-01-29
00810158218482PRINCETONPrinceton Medical Group, Inc.HXL2026-01-15
03662663154543SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663154581SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663155601Zyston Interbody Spacer SystemHighridge Medical, LLCHXL2025-12-29
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03662663217002Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHXL2025-11-17
03662663267199Timberline Lateral Fusion SystemHighridge Medical, LLCHXL2025-11-16
00887868294976TM Ardis Interbody SystemHighridge Medical, LLCHXL2025-11-14
03662663129831Disc Preparation InstrumentsHighridge Medical, LLCHXL2025-11-14
00810135963657ImpactNVISION BIOMEDICAL TECHNOLOGIES, INC.HXL2025-09-24
00810189110526MALLETOsteocentric Technologies, Inc.HXL2025-09-22
B382SD914554370Surgical DirectSurgical Direct, Inc.HXL2025-09-12
B382SD91455610310Surgical DirectSurgical Direct, Inc.HXL2025-09-12
00840314269812gSourceGSOURCE LLCHXL2025-08-29
00850078230041Disruptive MedTechMAHE MEDICAL USA LLCHXL2025-08-14
00757770423750Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08
00757770428953Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08
00763000879570Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.HXL2025-08-02
00192896121850Nylon Head For Deluxe MalletSONTEC INSTRUMENTS, INC.HXL2025-08-01
00192896121867Nylon Head For Deluxe MalletSONTEC INSTRUMENTS, INC.HXL2025-08-01
00194613005887MSI Precision Specialty InstrumentsMed Saver, Inc.HXL2025-08-01
00194613014001MSI Precision Specialty InstrumentsMed Saver, Inc.HXL2025-08-01