62-02331

GUDID 07613327291339

PEDIATRIC MANDIBULAR DISTRACTOR 2

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor
Primary Device ID07613327291339
NIH Device Record Keybad29112-3db1-456d-bbcd-e420c927a3c5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number62-02331
Catalog Number62-02331
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327291339 [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

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07613327547429 - DELTA2024-09-27 Delta wide-fit screwdriver blade
07613327547436 - DELTA2024-09-27 Delta wide-fit screwdriver blade
07613327547443 - DELTA2024-09-27 Delta wide-fit screwdriver blade
07613327547450 - DELTA2024-09-27 Delta wide-fit screwdriver blade
07613327547467 - DELTA2024-09-27 Delta wide-fit screwdriver blade
07613327547474 - DELTA2024-09-27 Delta wide-fit screwdriver blade
07613327616118 - N/A2024-08-30 Spine Guidance 5 Software

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