62-01321

GUDID 07613252634348

PED. MAND. DISTRACTOR, 2x2 RIGHT, 20 MM

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor
Primary Device ID07613252634348
NIH Device Record Keyb9df9eee-dfcf-4491-baa1-e23e52c66605
Commercial Distribution StatusIn Commercial Distribution
Version Model Number62-01321
Catalog Number62-01321
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

Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613252634348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613252634348]

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

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.