FDA.report

Shukla Nail S9NAIL

Primary DI
B756SOS0270
Brand
Shukla Nail S9NAIL
Company
Shukla Medical
Model
SOS027
Device description
Chisel, Bone
Published
2021-07-08
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
HWMOsteotome

Product Code Classifications

CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B756SOS0270PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1-727-626-2770CS@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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B756SBLDFLAT140Shukla Blade S9BLADESBLDFLAT-142025-03-25
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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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