Fascile Continuous Peripheral Nerve Block Set 500001-02

GUDID B3723000301025

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 IDB3723000301025
NIH Device Record Key6f1de0a4-0398-41ba-8b0b-f281a1f01082
Commercial Distribution StatusIn Commercial Distribution
Brand NameFascile Continuous Peripheral Nerve Block Set
Version Model Number70mm, Kit without filter
Catalog Number500001-02
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
HIBCCB3723000301025 [Package]
Contains: B372500001021
Package: Box of 5 [5 Units]
In Commercial Distribution
HIBCCB372500001021 [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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