62-01330

GUDID 07613252634393

PED. MAND. DISTRACTOR, 2x2 LEFT, 30 MM

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor
Primary Device ID07613252634393
NIH Device Record Keyb788e1b8-00e5-4537-8a32-fd8dd987c75c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number62-01330
Catalog Number62-01330
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613252634393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613252634393]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2015-09-24

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327300024 - NA2024-04-18
07613327556285 - NA2024-02-27 Facial iD MF 1 Mesh
07613327556308 - NA2024-02-23 Facial iD MF 2 meshes
07613327556322 - NA2024-02-23 Facial iD MF 3 meshes
07613327556346 - NA2024-02-23 Facial iD MF 4 meshes
07613327556377 - NA2024-02-23 Facial iD MF 5 meshes
07613327556391 - NA2024-02-23 Facial iD MF 6 meshes
07613327556827 - NA2024-02-23 Facial iD MF 1 mesh kit

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