4740015

GUDID 07613327401554

SternalPlate, T

Stryker Leibinger GmbH & Co. KG

Sternal fixation device
Primary Device ID07613327401554
NIH Device Record Key8cefed2d-98d5-4a4a-b407-9ffc85864a2d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4740015
Catalog Number4740015
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327401554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327401554]

Moist Heat or Steam Sterilization


[07613327401554]

Moist Heat or Steam Sterilization


[07613327401554]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-17
Device Publish Date2025-01-09

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327401523 - NA2025-01-17 SternalPlate, Transverse, w/ bars
07613327401554 - NA2025-01-17SternalPlate, T
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.