mytaMed mV-1034

GUDID B351MV10340

mytaView Rhinolaryngoscope, 3.4 x 300mm

Mytamed, Inc.

Flexible fibreoptic sinoscope

• Primary Device ID: B351MV10340
• NIH Device Record Key: 5b5edeaa-a1ba-4a64-be65-1d23bc5a2a9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mytaMed
• Version Model Number: mV-1034
• Catalog Number: mV-1034
• Company DUNS: 015903922
• Company Name: Mytamed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B351MV10340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030572

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B351MV10340]

High-level Disinfectant;Hydrogen Peroxide;Peracetic Acid

[B351MV10340]

High-level Disinfectant;Hydrogen Peroxide;Peracetic Acid

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [mytaMed]

• B351MY40000: mytaView ac Rigid ENT Endoscope, 4.0 x 185mm, 0 degree
• B351MVLLS4LBTP0: Rover IV Portable LED Light Source Complete with Charger and Batteries
• B351MV895440690: mytaView Leak Tester
• B351MV895428010: mytaView to Storz / Olympus Adapter
• B351MV895387430: mytaView Sheath, ac Rigid Sinuscopes
• B351MV895307380: mytaView to Wolf Adapter
• B351MV83000145090: mytaView ETO Caps
• B351MV80030: Med-Cam Endocoupler, 28mm
• B351MV80020: Med-Cam HD Camera Head
• B351MV80010: Med-Cam HD CCU
• B351MV80000: Med-Cam HD Camera System, Complete
• B351MV40700: mytaView ac Rigid ENT Endoscope, 4.0 x 185mm, 70 degree
• B351MV40450: mytaView ac Rigid ENT Endoscope, 4.0 x 185mm, 45 degree
• B351MV40300: mytaView ac Rigid ENT Endoscope, 4.0 x 185mm, 30 degree
• B351MV30700: mytaView ac Rigid ENT Endoscope, 3.0 x 150mm, 70 degree
• B351MV30450: mytaView ac Rigid ENT Endoscope, 3.0 x 150mm, 45 degree
• B351MV30300: mytaView ac Rigid ENT Endoscope, 3.0 x 150mm, 30 degree
• B351MV30000: mytaView ac Rigid ENT Endoscope, 3.0 x 150mm, 0 degree
• B351MV27700: mytaView ac Rigid ENT Endoscope, 2.7 x 140mm, 70 degree
• B351MV27300: mytaView ac Rigid ENT Endoscope, 2.7 x 140mm, 30 degree
• B351MV27000: mytaView ac Rigid ENT Endoscope, 2.7 x 140mm, 0 degree
• B351MV10340: mytaView Rhinolaryngoscope, 3.4 x 300mm
• B351MV10000: mytaView Rhinolaryngoscope, 3.6 x 300mm
• B351MN48470: Army-Navy Retractor Set, Double-Ended
• B351MLGS4X6ST0: Fiberoptic Light Cable, 4X6, K. Storz (source) to K. Storz (instrument)
• B351MLGS4X6AC0: Fiberoptic Light Cable, 4X6, K. Storz (source) to ACMI (instrument)
• B351MLGO4X6ST0: Fiberoptic Light Cable, 4X6, Olympus (source) to K. Storz (instrument)
• B351MLGO4X6AC0: Fiberoptic Light Cable, 4X6, Olympus (source) to ACMI (instrument)
• B351MLGA4X6ST0: Fiberoptic Light Cable, 4X6, ACMI (source) to K. Storz (instrument)
• B351MLGA4X6AC0: Fiberoptic Light Cable, 4X6, ACMI (source) to ACMI (instrument)
• B351ME16540: Lester Fixation Forceps, 1x2 Teeth
• B351810100: Laryngeal Mirror with Handle, #10 (30mm)
• B351810090: Laryngeal Mirror with Handle, #9 (28mm)
• B351810080: Laryngeal Mirror with Handle, #8 (26mm)
• B351810070: Laryngeal Mirror with Handle, #7 (24mm)
• B351810060: Laryngeal Mirror with Handle, #6 (22mm)
• B351810050: Laryngeal Mirror with Handle, #5 (20mm)
• B351810040: Laryngeal Mirror with Handle, #4 (18mm)
• B351810030: Laryngeal Mirror with Handle, #3 (16mm)
• B351810020: Laryngeal Mirror with Handle, #2 (14mm)
• B351810010: Laryngeal Mirror with Handle, #1 (12mm)
• B3518100000: Laryngeal Mirror with Handle, #00, (8mm)
• B351810000: Laryngeal Mirror with Handle, #0 (10mm)
• B351801010: Grooved Director, 14.5cm
• B351800020: Wieder Tongue Depressor, Large
• B351800010: Wieder Tongue Depressor, Small
• B351799010: Snare Wire, Nasal, 12 Pack
• B351799000: Krause Snare, Nasal
• B351755570: Schmeden Conchotome, 7.0mm Triangular Jaws
• B351754010: Giraffe Forceps, 55 Deg., 3.0mm, Vertical