DEVICE: Paltop (07290108691733)

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Device Identifier (DI) Information

Paltop
60-70042
60-70042
PALTOP ADVANCED DENTAL SOLUTIONS LTD
07290108691733
GS1
1
Torque Ratchet
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental torque wrench A hand-held dental device used to manually tighten, with an appropriate torque, dental implants and/or retaining screws fitted into the oral cavity during a dental surgical procedure. It will typically have a built-in ratchet function with forward and reverse direction and a calibrated scale to which a recommended torque can be set, allowing the operator to avoid under- or over-tightening of the implant/component. It will typically be made of high-grade stainless steel and have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
DZI Drill, Bone, Powered
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Sterilization

No
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 Status

In Commercial Distribution
December 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+97246271711
info@paltopdental.com
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