DEVICE: Screwdriver with Torque Limiter (Torx) (07290115934465)

Device Identifier (DI) Information

Screwdriver with Torque Limiter (Torx)
86567
In Commercial Distribution

PREMIA SPINE LTD
07290115934465
GS1

1
649220779 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47858 Surgical instrument torque limiter
A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
NKB Thoracolumbosacral Pedicle Screw System
MNI Orthosis, Spinal Pedicle Fixation
MNH Orthosis, Spondylolisthesis Spinal Fixation
QWK Prosthesis, Posterior Spinal Elements
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150380 000
K170061 000
K182598 000
K231844 000
P220002 000
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Sterilization

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Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0791751d-1523-40e1-9794-8bb1622b9115
September 27, 2024
2
September 03, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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