LAVA-18, 2 mL

GUDID 00850055697003

Embolization particle, non-bioabsorbable

Primary Device ID	00850055697003
NIH Device Record Key	0ec3f928-dc77-4731-b94d-1621eeec6048
Commercial Distribution Status	In Commercial Distribution
Brand Name	LAVA-18, 2 mL
Version Model Number	SLLES182
Company DUNS	111242823
Company Name	Blackswan Vascular, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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 Issuing Agency	Device ID
GS1	00850055697003 [Primary]

QVG	Embolization Agent, Vascular

Steralize Prior To Use	false
Device Is Sterile	true

00850055697003 - LAVA-18, 2 mL	2023-10-31LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL
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00850055697041 - LAVA Mixing Kit, 2 mL	2023-10-31 LAVA Mixing Kit, 2 mL (to homogenize the liquid embolic suspension)
00850055697058 - LAVA Mixing Kit, 6 mL	2023-10-31 LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)