DEVICE: Zeramex XT Surgery Tray, fully equipped, without drills (07640161392823)

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Device Record History
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Device Identifier (DI) Information
Zeramex XT Surgery Tray, fully equipped, without drills
XT48865
Not in Commercial Distribution
XT48865
CeramTec Schweiz GmbH
07640161392823
GS1
March 04, 2025
1
483229493 *Terms of Use
Tools
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
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?
45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable
A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry, Keep out of sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
2a053d56-8c8c-4b21-a377-7ffa3592f44c
March 05, 2025
3
November 30, 2018
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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

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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
Yes
No CLOSE

Customer Contact

[?]
+41443883636
mpd.regulatory@ceramtec.de
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