BEAR mV-4000

GUDID B351MV40000

mView Rigid ENT Endoscope, 4.0 x 185mm, 0 Deg.

Mytamed, Inc.

Rigid sinoscope

• Primary Device ID: B351MV40000
• NIH Device Record Key: dfa68ca1-7bde-44fc-a2dc-fdde7643f0ab
• Commercial Distribution Discontinuation: 2020-03-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BEAR
• Version Model Number: mV-4000
• Catalog Number: mV-4000
• 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	B351MV40000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981751

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

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

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

[B351MV40000]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid;High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-19
• Device Publish Date: 2020-03-11

On-Brand Devices [BEAR]

• B351MV40000: mView Rigid ENT Endoscope, 4.0 x 185mm, 0 Deg.
• B351B656130: Angled Ear Needle, 30 Deg., Blunt Tip
• B351B656120: Angled Ear Needle, 30 Deg., Sharp Tip
• B351B656110: Rosen Ear Needle, Blunt Tip, Strong Curve
• B351B656100: Rosen Ear Needle, Blunt Tip, Medium Curve
• B351B656090: Rosen Ear Needle, Blunt Tip, Light Curve
• B351B656080: Rosen Ear Needle, Sharp Tip, Strong Curve
• B351B656070: Rosen Ear Needle, Sharp Tip, Medium Curve
• B351B656060: Rosen Ear Needle, Sharp Tip, Light Curve
• B351B706260: Weil-Blakesley Forceps, 2.5mm, Straight
• B351BMLGS4X7ST0: Fiberoptic Light Cable, 7.5' Storz to Storz
• B351BMLGS4X6ST0: Fiberoptic Light Cable, 6.0' Storz to Storz
• B351B735040: Cottle Elevator, Double-Ended, Flat Handle
• B351B735020: Freer Elevator, Double-Ended, Round Handle
• B351B714030: Vienna Nasal Specula, No.3, Large
• B351B714020: Vienna Nasal Specula, No.2, Medium
• B351B714010: Vienna Nasal Specula, No.1, Small
• B351B624010: McKenna Crimping Forceps with Spring
• B351B608290: Farrior Ear Specula, Oval, 7.5 x 8.5mm
• B351B608280: Farrior Ear Specula, Oval, 7.0 x 8.0mm
• B351B608270: Farrior Ear Specula, Oval, 6.5 x 7.5mm
• B351B608260: Farrior Ear Specula, Oval, 6.0 x 7.0mm
• B351B608250: Farrior Ear Specula, Oval, 5.5 x 6.5mm
• B351B608240: Farrior Ear Specula, Oval, 5.0 x 6.0mm
• B351B608230: Farrior Ear Specula, Oval, 4.5 x 5.5mm
• B351B608220: Farrior Ear Specula, Oval, 4.0 x 5.0mm
• B351B608210: Farrior Ear Specula, Oval, 3.0 x 4.0mm
• B351B606800: Ebonized Ear Specula, Oval-Oblique, 8.0 x 9.0mm
• B351B606750: Ebonized Ear Specula, Oval-Oblique, 7.5 x 8.5mm
• B351B606700: Ebonized Ear Specula, Oval-Oblique, 7.0 x 8.0mm
• B351B606650: Ebonized Ear Specula, Oval-Oblique, 6.5 x 7.5mm
• B351B606600: Ebonized Ear Specula, Oval-Oblique, 6.0 x 7.0mm
• B351B606550: Ebonized Ear Specula, Oval-Oblique, 5.5 x 6.5mm
• B351B606500: Ebonized Ear Specula, Oval-Oblique, 5.0 x 6.0mm
• B351B606450: Ebonized Ear Specula, Oval-Oblique, 4.5 x 5.5mm
• B351B606400: Ebonized Ear Specula, Oval-Oblique, 4.0 x 5.0mm
• B351B606350: Ebonized Ear Specula, Oval-Oblique, 3.5 x 4.5mm
• B351B606300: Ebonized Ear Specula, Oval-Oblique, 3.0 x 4.0mm
• B351B290010: Knife Handle, No.3
• B351B106010: Andrews-Pynchon Suction
• B351B100170: Baron Suction Tube, 7 Fr
• B351B100150: Baron Suction Tube, 5 Fr
• B351B100130: Baron Suction Tube, 3 Fr
• B35B1113060: Frazier-Ferguson Suction, 6 Fr
• B351B113150: Frazier-Ferguson Suction, 15 Fr
• B351B113140: Frazier-Ferguson Suction, 14 Fr
• B351B113130: Frazier-Ferguson Suction, 13 Fr
• B351B113120: Frazier-Ferguson Suction, 12 Fr
• B351B113110: Frazier-Ferguson Suction, 11 Fr
• B351B113100: Frazier-Ferguson Suction, 10 Fr