| Primary Device ID | 04580036673646 |
| NIH Device Record Key | 23179411-ce87-461c-8a5f-517d82e8d5a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Super Bypass |
| Version Model Number | SBTi-1210 |
| Catalog Number | SBTi-1210 |
| Company DUNS | 707948014 |
| Company Name | TAKAYAMA INSTRUMENTS INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04580036673646 [Primary] |
| GEN | Forceps, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
[04580036673646]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-04 |
| Device Publish Date | 2025-06-26 |
| 04580036675121 | Stylet Insert Cover (2pcs) |
| 04580036675114 | Suction-Irrigation MiNi Hand-Piece, Left-Handed |
| 04580036675107 | Suction-Irrigation MiNi system starter kit 1 Left-Handed (1 HP, 4 Tips, 2 Stylets ,2 Stylet Inse |
| 04580036675084 | Suction-Irrigation MiNi Hand-Piece |
| 04580036675077 | Suction-Irrigation MiNi system starter kit 1 (1 HP, 4 Tips, 2 Stylets ,2 Stylet Insert Cover) |
| 04580036674230 | L-Wrench for Rotor-Cap |
| 04580036674223 | Cleaning Stylet for Tips |
| 04580036674216 | Cleaning Stylet for Hand-Piece |
| 04580036674209 | SuperBypass SI system Tip, 180mm, 3.0mm [9Fr] (NON Pre-sterilized) |
| 04580036674193 | SuperBypass SI system Tip, 180mm, 2.0mm [6Fr] (NON Pre-sterilized) |
| 04580036674186 | SuperBypass SI system Tip, 180mm, 1.5mm [4.5Fr] (NON Pre-sterilized) |
| 04580036674179 | SuperBypass SI system Tip, 180mm, 1.2mm [3.6Fr] (NON Pre-sterilized) |
| 04580036674162 | SuperBypass SI system Tip, 160mm, 3.0mm [9Fr] (NON Pre-sterilized) |
| 04580036674155 | SuperBypass SI system Tip, 160mm, 2.0mm [6Fr] (NON Pre-sterilized) |
| 04580036674148 | SuperBypass SI system Tip, 160mm, 1.5mm [4.5Fr] (NON Pre-sterilized) |
| 04580036674131 | SuperBypass SI system Tip, 160mm, 1.2mm [3.6Fr] (NON Pre-sterilized) |
| 04580036674124 | SuperBypass SI system Tip, 130mm, 3.0mm [9Fr] (NON Pre-sterilized) |
| 04580036674117 | SuperBypass SI system Tip, 130mm, 2.0mm [6Fr] (NON Pre-sterilized) |
| 04580036674100 | SuperBypass SI system Tip, 130mm, 1.5mm [4.5Fr] (NON Pre-sterilized) |
| 04580036674094 | SuperBypass SI system Tip, 130mm, 1.2mm [3.6Fr] (NON Pre-sterilized) |
| 04580036674087 | SuperBypass SI system Tip, 110mm, 3.0mm [9Fr] (NON Pre-sterilized) |
| 04580036674070 | SuperBypass SI system Tip, 110mm, 2.0mm [6Fr] (NON Pre-sterilized) |
| 04580036674063 | SuperBypass SI system Tip, 110mm, 1.5mm [4.5Fr] (NON Pre-sterilized) |
| 04580036674056 | SuperBypass SI system Tip, 110mm, 1.2mm [3.6Fr] (NON Pre-sterilized) |
| 04580036674049 | SuperBypass SI system Tip, 70mm, 3.0mm [9Fr] (NON Pre-sterilized) |
| 04580036674032 | SuperBypass SI system Tip, 70mm, 2.0mm [6Fr] (NON Pre-sterilized) |
| 04580036674025 | SuperBypass SI system Tip, 70mm, 1.5mm [4.5Fr] (NON Pre-sterilized) |
| 04580036674018 | SuperBypass SI system Tip, 70mm, 1.2mm [3.6Fr] (NON Pre-sterilized) |
| 04580036674001 | SuperBypass SI system Tip, 90mm, 3.0mm [9Fr] (NON Pre-sterilized) |
| 04580036673998 | SuperBypass SI system Tip, 90mm, 2.0mm [6Fr] (NON Pre-sterilized) |
| 04580036673981 | SuperBypass SI system Tip, 90mm, 1.5mm [4.5Fr] (NON Pre-sterilized) |
| 04580036673974 | SuperBypass SI system Tip, 90mm, 1.2mm [3.6Fr] (NON Pre-sterilized) |
| 04580036673967 | Suction-Irrigation, Hand-Piece, Left-Handed |
| 04580036673950 | Suction-Irrigation, Hand-Piece |
| 04580036673943 | Suction-Irrigation system starter kit 1 Left-Handed (1 HP, 4 Tips, 2 Stylets, 1 L-Wrench) |
| 04580036673936 | Suction-Irrigation system starter kit 1 (1 HP, 4 Tips, 2 Stylets, 1 L-Wrench) |
| 04580036673929 | Titanium, Micro Needle Holder Bayonet, 175mm (70mm W.L.), 60degree, Small Tip |
| 04580036673912 | Titanium, Micro Needle Holder Bayonet, 175mm (70mm W.L.), 60degree, |
| 04580036673905 | Titanium, Micro Needle Holder Bayonet, 175mm (70mm W.L.), 45degree, |
| 04580036673899 | Titanium, Micro Needle Holder Bayonet, 175mm (70mm W.L.), 30degree, |
| 04580036673882 | Titanium, Micro Needle Holder Bayonet, 195mm (90mm W.L.), 60degree, Small Tip |
| 04580036673875 | Titanium, Micro Needle Holder Bayonet, 195mm (90mm W.L.), 45degree, Small Tip |
| 04580036673868 | Titanium, Micro Needle Holder Bayonet, 195mm (90mm W.L.), 30degree, Small Tip |
| 04580036673851 | Titanium, Micro Needle Holder Bayonet, 195mm (90mm W.L.), 60degree, |
| 04580036673844 | Titanium, Micro Needle Holder Bayonet, 195mm (90mm W.L.), 45degree, |
| 04580036673837 | Titanium, Micro Needle Holder Bayonet, 195mm (90mm W.L.), 30degree, |
| 04580036673820 | Titanium, Micro Needle Holder Bayonet, 215mm (110mm W.L.), 60degree, Small Tip |
| 04580036673813 | Titanium, Micro Needle Holder Bayonet, 215mm (110mm W.L.), 45degree, Small Tip |
| 04580036673806 | Titanium, Micro Needle Holder Bayonet, 215mm (110mm W.L.), 30degree, Small Tip |
| 04580036673790 | Titanium, Micro Needle Holder Bayonet, 215mm (110mm W.L.), 60degree, |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUPER BYPASS 88939761 not registered Live/Pending |
TAKAYAMA Instrument, Inc. 2020-05-29 |
![]() SUPER BYPASS 79127103 4430642 Live/Registered |
GUNZE LIMITED 2012-12-27 |