Fascile Continuous Peripheral Nerve Block Set 500003-01

GUDID B3723000303015

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is

SOLODEX LLC

Peripheral nerve-block sharp needle
Primary Device IDB3723000303015
NIH Device Record Keybb70683b-9831-493e-96d2-0a0992abfebd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFascile Continuous Peripheral Nerve Block Set
Version Model Number150mm, Kit with filter
Catalog Number500003-01
Company DUNS070980116
Company NameSOLODEX LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com
Phone303-531-1238
EmailSolo-Dex@solo-dex.com

Device Dimensions

Length150 Millimeter
Length150 Millimeter
Length150 Millimeter
Length150 Millimeter
Length150 Millimeter
Length150 Millimeter
Length150 Millimeter
Length150 Millimeter
Length150 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3723000303015 [Package]
Contains: B372500003011
Package: Box of 5 [5 Units]
In Commercial Distribution
HIBCCB372500003011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-24
Device Publish Date2016-09-26

On-Brand Devices [Fascile Continuous Peripheral Nerve Block Set]

B3723000303025Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised
B3723000303015Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised
B3723000301025Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised
B3723000301015Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised

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