FDA.report

Shukla Anterior Hip S9HIP-ANT

Primary DI
B756SMT0050
Brand
Shukla Anterior Hip S9HIP-ANT
Company
Shukla Medical
Model
SMT005
Device description
Mallet, Large Handle, Assy
Published
2022-06-03
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B756SMT0050PrimaryHIBCC0

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
+1-727-626-2771CS@ShuklaMedical.com

Regulatory Flags

DUNS number
159009294
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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B756SBLDFLAT130Shukla Blade S9BLADESBLDFLAT-132025-03-25
B756SBLDFLAT140Shukla Blade S9BLADESBLDFLAT-142025-03-25
B756SDR9010Shukla Hip S9HIPSDR9012025-02-14
B756SBLDACE42SP1Shukla Acetabular Cup - S9CUPSBLDACE-42-SP2024-11-07
B756SBLDACE44SP1Shukla Acetabular Cup - S9CUPSBLDACE-44-SP2024-11-07
B756SBLDACE46SP1Shukla Acetabular Cup - S9CUPSBLDACE-46-SP2024-11-07
B756SBLDACE48SP1Shukla Acetabular Cup - S9CUPSBLDACE-48-SP2024-11-07
B756SBLDACE50SP1Shukla Acetabular Cup - S9CUPSBLDACE-50-SP2024-11-07
B756SBLDACE52SP1Shukla Acetabular Cup - S9CUPSBLDACE-52-SP2024-11-07
B756SBLDACE54SP1Shukla Acetabular Cup - S9CUPSBLDACE-54-SP2024-11-07
B756SBLDACE56SP1Shukla Acetabular Cup - S9CUPSBLDACE-56-SP2024-11-07
B756SBLDACE58SP1Shukla Acetabular Cup - S9CUPSBLDACE-58-SP2024-11-07
B756SBLDACE60SP1Shukla Acetabular Cup - S9CUPSBLDACE-60-SP2024-11-07
B756SBLDACE62SP1Shukla Acetabular Cup - S9CUPSBLDACE-62-SP2024-11-07
B756SBLDACE64SP1Shukla Acetabular Cup - S9CUPSBLDACE-64-SP2024-11-07
B756SBLDACE66SP1Shukla Acetabular Cup - S9CUPSBLDACE-66-SP2024-11-07
B756SBLDACE68SP1Shukla Acetabular Cup - S9CUPSBLDACE-68-SP2024-11-07
B756SBLDACE70SP1Shukla Acetabular Cup - S9CUPSBLDACE-70-SP2024-11-07
B756SBLDACE72SP1Shukla Acetabular Cup - S9CUPSBLDACE-72-SP2024-11-07
B756SBD0080Shukla Knee S9KNEESBD008SBD0082020-11-16

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