DEVICE: NA (00844868018704)

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Device Identifier (DI) Information

NA
XDG2320

BIOMET 3I, LLC
00844868018704
GS1
1
GELB X-RAY DEPTH GAGE 2.3MM(D) X 20MM(L)
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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
Implant-depth dental gauge A hand-held dental instrument used in surgical implant procedures to accurately measure various depths. This device has graduations on the measuring tip denoting specific depths (typically in millimetres) which are used at the fixture level (where a device is surgically implanted into the mandible or maxilla) to determine the correct drill depth of the implant site, or at the abutment level (where a device is screwed into the implanted fixture) for measuring the soft tissues and the mucosal height over the fixture. The device is typically available in a set of graduated sizes. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
NDP ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
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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
Length: 20 Millimeter
Device Size Text, specify: Diameter 2.3 mm
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Device Status

In Commercial Distribution
March 24, 2016

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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

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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

[?]
+1(800)342-5454
3iPBG-CS@biomet.com
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