Fascile Continuous Peripheral Nerve Block Set 500001-01

GUDID B3723000301015

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 IDB3723000301015
NIH Device Record Key8c79b3cf-dece-4d53-977e-68fd293ec615
Commercial Distribution Discontinuation2018-07-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFascile Continuous Peripheral Nerve Block Set
Version Model Number70mm, Kit with filter
Catalog Number500001-01
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

Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3721001385 [Package]
Contains: B372500001011
Package: Box of 5 [5 Units]
Discontinued: 2018-07-19
Not in Commercial Distribution
HIBCCB3723000301015 [Package]
Contains: B372500001011
Package: Box of 5 [5 Units]
Discontinued: 2018-07-19
Not in Commercial Distribution
HIBCCB372500001011 [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 Date2018-07-23
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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