DePuy Songer® Spinal Cable System 7825-130

GUDID 10846468005372

Pioneer Surgical Technology, Inc.

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Primary Device ID	10846468005372
NIH Device Record Key	d57a47c2-f804-4792-91b3-9ed351c0c31c
Commercial Distribution Status	In Commercial Distribution
Brand Name	DePuy Songer® Spinal Cable System
Version Model Number	400-067
Catalog Number	7825-130
Company DUNS	793384496
Company Name	Pioneer Surgical Technology, Inc.
Device Count	1
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	10846468005372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K935481

FDA Product Code

HWN	Instrument, Compression
JDQ	Cerclage, Fixation