| Primary Device ID | B351735060 |
| NIH Device Record Key | 1303d519-291b-43ed-86c6-0bb740a6c331 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | mytaMed |
| Version Model Number | 7.35.06 |
| Catalog Number | 7.35.06 |
| Company DUNS | 015903922 |
| Company Name | Mytamed, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B351735060 [Primary] |
| HTE | Elevator |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
[B351735060]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-11 |
| Device Publish Date | 2022-04-01 |
| 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 |