92-02322

GUDID 07613327504415

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor

Primary Device ID	07613327504415
NIH Device Record Key	41f4682c-a796-46e7-84b2-8e48bed8a62f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	92-02322
Catalog Number	92-02322
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Length	60 Millimeter
Height	5 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327504415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181504

FDA Product Code

MQN	EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-10-27
Device Publish Date	2020-05-12

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