DEVICE: NA (04546540695253)
Device Identifier (DI) Information
NA
62-08430
In Commercial Distribution
62-08430
Stryker Leibinger GmbH & Co. KG
62-08430
In Commercial Distribution
62-08430
Stryker Leibinger GmbH & Co. KG
UNIVERSAL MANDIBLE DEPTH GAUGE, BLACK
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 |
---|---|
Surgical depth gauge, reusable | A surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess; when the tip makes contact with the bottom a reading is visually taken from a scale marked on the side of the device. It is often used to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It is made of corrosive resistant materials [e.g., stainless steel, titanium (Ti)]. This is a reusable device intended to be sterilized prior to use. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 22.0 Centimeter |
Device Record Status
77ad74db-7998-4da0-8d3c-a36b55bbcbfc
March 29, 2018
2
October 19, 2016
March 29, 2018
2
October 19, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined