FDA.reportPublic FDA data

Fascile Continuous Peripheral Nerve Block Set

Primary DI
B3723000301025
Brand
Fascile Continuous Peripheral Nerve Block Set
Company
SOLODEX LLC
Model
70mm, Kit without filter
Catalog number
500001-02
Device description
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
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151072000Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle KitSolo-Dex, Inc.2016-01-22BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3723000301025PackageHIBCC5In Commercial Distribution
B372500001021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral nerve-block sharp needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-531-1238Solo-Dex@solo-dex.com

Regulatory Flags#

DUNS number
070980116
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3723000303015Fascile Continuous Peripheral Nerve Block Set150mm, Kit with filter500003-012016-09-26
B3723000303025Fascile Continuous Peripheral Nerve Block Set150mm, Kit without filter500003-022016-09-26
B3723000301015Fascile Continuous Peripheral Nerve Block Set70mm, Kit with filter500001-012016-09-26

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Primary DI, Brand, Company table
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