62-02320

GUDID 07613327291377

PEDIATRIC MANDIBULAR DISTRACTOR 2

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor
Primary Device ID07613327291377
NIH Device Record Keyc89b3922-9ecf-474c-be55-b5d51114fd2a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number62-02320
Catalog Number62-02320
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width15 Millimeter
Width15 Millimeter
Width15 Millimeter
Width15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327291377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-23
Device Publish Date2018-09-20

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327401523 - NA2025-01-17 SternalPlate, Transverse, w/ bars
07613327401554 - NA2025-01-17 SternalPlate, T
07613327401561 - NA2025-01-17 SternalPlate, Transverse, w/ bars
07613327401738 - NA2025-01-17 SternalPlate, T
07613327634952 - NA2024-12-16 Drill for 6514-7-200 WL 16mm
07613327634969 - NA2024-12-16 Drill for 6514-7-200 WL 12mm
07613327634976 - NA2024-12-16 Drill for 6514-7-200 WL 10mm
07613327634983 - NA2024-12-16 Drill for 6514-7-200 WL 12mm

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