Isto Plus Flow 1.0cc - Syringe

GUDID 00849777012171

Bone matrix implant, human-derived

Primary Device ID	00849777012171
NIH Device Record Key	b42799cd-45fb-41c4-b92c-29903907d1e1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Isto Plus Flow 1.0cc - Syringe
Version Model Number	ISTO-FW-01
Company DUNS	081224143
Company Name	Xtant Medical Holdings, Inc.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	true
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	true
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00849777012171 [Primary]

MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Steralize Prior To Use	false
Device Is Sterile	true

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