DEVICE: WIRE BONDER (D9097000011)

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Device Record History
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Device Identifier (DI) Information
WIRE BONDER
700-001
In Commercial Distribution
700-001
Ortho Arch Company Inc
D9097000011
HIBCC

1
020956330 *Terms of Use
WIRE BONDER LG TIPS & HANDLE (10 TIPS)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
42344 Dental mould
A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EGD Wax, Dental, Intraoral
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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
abd5a76b-777c-46eb-9c7b-c5cca9395fb8
July 05, 2023
1
June 27, 2023
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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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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