FDA.reportPublic FDA data

Fascile Continuous Peripheral Nerve Block Set

Primary DI
B372500001011
Brand
Fascile Continuous Peripheral Nerve Block Set
Company
Solo-Dex, Inc
Model
70mm, Kit with filter
Catalog number
500001-01
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 comprised of different key components required to complete the Peripheral Nerve Block procedure.
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
B3721001385PackageHIBCC5Not in Commercial Distribution
B3723000301015PackageHIBCC5Not in Commercial Distribution
B372500001011PrimaryHIBCC0

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

Contacts#

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

Regulatory Flags#

DUNS number
118663297
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001913355Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000352023-08-08
00850001913041Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000082023-05-09
00850001913102Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000202023-05-09
00850001913157Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000302023-05-09
00850001913270Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000272023-05-09
10850001913048Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000082023-05-09
10850001913109Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000202023-05-09
10850001913154Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000302023-05-09
10850001913277Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000272023-05-09
08500019130009Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 5000142018-09-20
B372500001021Fascile Continuous Peripheral Nerve Block Set70mm, Kit without filter500001-022016-09-26
B372500003011Fascile Continuous Peripheral Nerve Block Set150mm, Kit with filter500003-012016-09-26
B372500003021Fascile Continuous Peripheral Nerve Block Set150mm, Kit without filter500003-022016-09-26

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