AccessGUDID - DEVICE: LAVA-18, 2 mL (00850055697003)

GUDID

Device Identifier (DI) Information

Brand Name: LAVA-18, 2 mL
Version or Model: SLLES182
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Blackswan Vascular, Inc.

Primary DI Number: 00850055697003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111242823 *Terms of Use

Device Description: LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67002	Non-neurovascular embolization plug, synthetic polymer	A non-bioabsorbable device intended to be implanted in a peripheral (non-neurovascular) artery for permanent/long-term occlusion of blood flow to treat haemorrhage. It is in the form of an injectable synthetic polymer solution [e.g., dissolved ethylene vinyl alcohol (EVOH)] that solidifies in situ to form a coherent embolus requiring no thrombosis to create blockage; radiopaque metal (e.g., tantalum) powder may be included to assist fluoroscopic visualization. It is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QVG	Embolization Agent, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220020	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ec3f928-dc77-4731-b94d-1621eeec6048
Public Version Date: February 19, 2024
Public Version Number: 3
DI Record Publish Date: October 23, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-474-7839
Email: csusa@sirtex.com

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