DEVICE: NA (07613252634386)

Device Identifier (DI) Information

NA
62-01333
In Commercial Distribution
62-01333
Stryker Leibinger GmbH & Co. KG
07613252634386
GS1

1
316153956 *Terms of Use
PED. MAND. DISTRACTOR, 3x3 RIGHT, 30 MM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Implantable craniofacial bone distractor A temporary implantable or partially-implantable device intended to 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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FDA Product Code

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Product Code Product Code Name
MQN EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 3D Plates: 3x3 Holes
Height: 5.0 Millimeter
Length: 70.0 Millimeter
Width: 30.0 Millimeter
Length: 30.0 Millimeter
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Device Record Status

bc4b4e19-30d3-459b-9ef7-a3edeac6e57b
March 29, 2018
2
September 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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