DEVICE: SurgiMac (D105SKU1311760)

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Device Record History
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Device Identifier (DI) Information
SurgiMac
13-1176
In Commercial Distribution
13-1176
Surgimac LLC
D105SKU1311760
HIBCC

1
060635048 *Terms of Use
Morrell-Type Crown Remover
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Device Characteristics
Labeling does not contain MRI Safety Information
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?
42395 Spring-loaded dental mallet
A hand-operated spring-loaded device with variable power intended to be used to condense gold (Au) foil or seating inlays. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EIS Remover, Crown
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
7783169f-a7c3-4f55-9e1c-7a5080e39a4a
May 20, 2024
1
May 10, 2024
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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
No Secondary DIs found
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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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