LAVA Mixing Kit, 2 mL

GUDID 00850055697041

LAVA Mixing Kit, 2 mL (to homogenize the liquid embolic suspension)

Blackswan Vascular, Inc.

Embolization particle, non-bioabsorbable
Primary Device ID00850055697041
NIH Device Record Key49866688-1a1d-4834-91cf-ce2e8f5e4343
Commercial Distribution StatusIn Commercial Distribution
Brand NameLAVA Mixing Kit, 2 mL
Version Model NumberSLLESMK2
Company DUNS111242823
Company NameBlackswan Vascular, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com
Phone1-888-474-7839
Emailcsusa@sirtex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850055697041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QVGEmbolization Agent, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-31
Device Publish Date2023-10-23

Devices Manufactured by Blackswan Vascular, Inc.

00850055697003 - LAVA-18, 2 mL2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL
00850055697010 - LAVA-34, 2 mL2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-34, 2 mL
00850055697027 - LAVA-18, 6 mL2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-18, 6 mL
00850055697034 - LAVA-34, 6 mL2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-34, 6 mL
00850055697041 - LAVA Mixing Kit, 2 mL 2023-10-31LAVA Mixing Kit, 2 mL (to homogenize the liquid embolic suspension)
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 mL2023-10-31 LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)

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