DEVICE: MEDENTiKA (04251574822833)

Device Identifier (DI) Information

MEDENTiKA
M 14
In Commercial Distribution
M 14
MEDENTiKA GmbH
04251574822833
GS1

1
537555497 *Terms of Use
ISO shank adapter
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Device Characteristics

MR Conditional
No
No
No
No
No
No
No
No

GMDN

[?]

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?
64373 Dental torque wrench adaptor
A component of a dental torque wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a specific endpiece(s). It is intended to be used during an invasive surgical procedure and is dedicated to dental use only. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NDP Accessories, implant, dental, endosseous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Compatible with Medentika
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Device Record Status

4c129c7b-d86b-41e4-b91b-4c3766110393
May 04, 2022
1
April 26, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
HIBCC EMKAM149
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Unit of Use DI

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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