DEVICE: NA (07613252634362)
Device Identifier (DI) Information
NA
62-01322
In Commercial Distribution
62-01322
Stryker Leibinger GmbH & Co. KG
62-01322
In Commercial Distribution
62-01322
Stryker Leibinger GmbH & Co. KG
PED. MAND. DISTRACTOR, 3x3 LEFT, 20 MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
47635 | Implantable craniofacial bone distractor |
An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K133398 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 3D Plates: 3x3 Holes |
Height: 5.0 Millimeter |
Width: 30.0 Millimeter |
Length: 60.0 Millimeter |
Length: 20.0 Millimeter |
Device Record Status
7d9504fc-fed3-4b0b-a750-91eb7ed7895c
September 23, 2019
4
September 24, 2015
September 23, 2019
4
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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