FDA.reportPublic FDA data

Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

Primary DI
00850001913270
Brand
Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Company
Solo-Dex, Inc
Model
500027
Device description
Needle 20 gauge, Catheter 4 French X 100 mm Mini Kit (50cm Extension, non-stimulation)
Published
2023-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

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
10850001913277PackageGS110In Commercial Distribution
20850001913274PackageGS1100In Commercial Distribution
00850001913270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000191327710850001913277
2085000191327420850001913274
00850001913270008500019132708500019132700850001913270

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118663297
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
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
B372500001011Fascile Continuous Peripheral Nerve Block Set70mm, Kit with filter500001-012016-09-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
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10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489250510Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
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10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
10193489550115MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-28
10193489270990MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-27
10680651479096HalyardAvanos Medical, Inc.BSP2019-07-15
10680651477566HalyardAvanos Medical, Inc.BSP2019-06-15
10680651478181HalyardAvanos Medical, Inc.BSP2019-06-15
10680651478785HalyardAvanos Medical, Inc.BSP2019-06-15
10680651476439HalyardAvanos Medical, Inc.BSP2019-02-21
10680651477061HalyardAvanos Medical, Inc.BSP2019-02-21