29-15964

GUDID 37613154572480

SCREWDISC,UN1,SELF-DRILLING,1.5x4mm,80PK

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile

Primary Device ID	37613154572480
NIH Device Record Key	2bd0bc26-7a52-43cb-8b83-ff133b3c91b3
Commercial Distribution Status	In Commercial Distribution
Version Model Number	29-15964
Catalog Number	29-15964
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	80
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154572489 [Unit of Use]
GS1	37613154572480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031659

FDA Product Code

JEY	PLATE, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

[37613154572480]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327634945 - NA	2024-10-01 Drill for 4/5mm screws SYK
07613327547429 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547436 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547443 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547450 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547467 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327547474 - DELTA	2024-09-27 Delta wide-fit screwdriver blade
07613327616118 - N/A	2024-08-30 Spine Guidance 5 Software

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