FDA.report

Shukla Nail-BR S9NAIL-BR

Primary DI
B756SSH055130
Brand
Shukla Nail-BR S9NAIL-BR
Company
Shukla Medical
Model
SSH055-13
Device description
Wire, Ball Tip, 58 cm length, 3 mm dia
Published
2021-07-16
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
true

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B756SSH055130PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use 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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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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