JAWS Staple System P70-294-2006

GUDID 00889795114143

JAW STAPLE SYS, SMOOTH LOC PIN

PARAGON 28, INC.

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Primary Device ID	00889795114143
NIH Device Record Key	253b6037-e5ee-44a6-9117-b9965d5bbad4
Commercial Distribution Status	In Commercial Distribution
Brand Name	JAWS Staple System
Version Model Number	P70-294-2006
Catalog Number	P70-294-2006
Company DUNS	042961576
Company Name	PARAGON 28, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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	true
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	00889795114143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170923

FDA Product Code

JDR	Staple, fixation, bone