FDA.reportPublic FDA data

Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm

Primary DI
B90823991238
Brand
Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm
Company
Mainstream Medical Devices, LLC
Model
239-91-238
Catalog number
IFLX-DFS-6mm
Device description
Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B90823991238PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative orthopaedic bone pin/screw, single-useA small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments/devices. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071513432
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B90831225080Main-Mallet312-25-080312-25-0802025-04-04
B90831625080Main-Mallet316-25-080316-25-0802025-04-04
B90831635080Main-Mallet316-35-080316-35-0802025-04-04
B908350011000Main-Mallet-Spinal Simplicity316-35-91135-0011-0002025-04-04
B908350008000Main-AXS Needle-Spinal Simplicity292-11-92035-0008-0002024-12-03
B908350009000Main-AXS Needle-Spinal Simplicity299-08-90035-0009-0002024-12-03
B90831020150Sterile Drill Bit310-20-150310-20-1502024-08-09
B90831020150907Sterile Drill Bit - RMR310-20-150-90707.20.QDS2024-08-09
B90831025150Sterile Drill Bit310-25-150310-25-1502024-08-09
B90831027150Sterile Drill Bit310-27-150310-27-1502024-08-09
B90831027150907Sterile Drill Bit - RMR310-27-150-90707.27.QDS2024-08-09
B90831032150Sterile Drill Bit310-32-150310-32-1502024-08-09
B90831032150907Sterile Drill Bit - RMR310-32-150-90707.32.QDS2024-08-09
B9081600051Main-Knife RIGID 21mm, Alphatec451-25-9011600-052024-03-02
B9081600060Main-Knife - Alphatec471-25-9011600-062024-03-02
B90847125901Main-Knife - Alphatec471-25-9011600-062024-02-21
B90845125901Main-Knife RIGID 21mm, Alphatec451-25-9011600-052023-07-12
B90847125193Main-Knife - Alphatec471-25-193471-25-1932024-02-21

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Primary DI, Brand, Company table
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00846338005436Working PortELLIQUENCE, LLCGEA2026-06-02
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00846338005535Suction TubeELLIQUENCE, LLCGEA2026-06-01
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00810130456390Medco ManufacturingMedco Manufacturing LLCGEA2026-05-29
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
00840329837365BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-05-04
G589DS22G501DermaSculptCosmoFranceGEA2026-04-13
G589DS22G701DermaSculptCosmoFranceGEA2026-04-13
G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13