390182

GUDID 07613327072631

KIRSCHNER WIRE

Stryker Trauma SA

Orthopaedic bone wire

Primary Device ID	07613327072631
NIH Device Record Key	0d264bf4-437b-481e-aac5-b5485930779c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	390182
Catalog Number	390182
Company DUNS	481999654
Company Name	Stryker Trauma SA
Device Count	10
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	07613327072631 [Unit of Use]
GS1	37613327072632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K971962

FDA Product Code

HTY	PIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

[07613327072631]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-11-04
Device Publish Date	2021-10-27

Devices Manufactured by Stryker Trauma SA

07613327614633 - PANGEA	2024-12-09 Tap, Locking, AO
07613327624786 - PANGEA	2024-12-09 Drill Bit, MIS, AO
07613327624809 - PANGEA	2024-12-09 Tissue Protection Sleeve, MIS
07613327624816 - PANGEA	2024-12-09 Variable Angle Drill Guide, MIS
07613327624830 - PANGEA	2024-12-09 Aiming Block Distal Lateral Femur MIS, L
07613327624847 - PANGEA	2024-12-09 Plate Hole Marker, MIS
07613327624861 - PANGEA	2024-12-09 Plate Hole Marker, MIS
07613327624878 - PANGEA	2024-12-09 Drill Sleeve Insert, MIS

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