FDA Registration
Active
🇯🇵 Japan
TR-125/14AGF BEVEL UP, 45 DEGREE BENT 1.25x1.4 ANTI-GLARE TYPE
Reg #: 8031525
·
FEI: 6827
·
Expires 2025
Products
1
Proprietary Names
94
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KAI INDUSTRIES CO., LTD.
- Registration Number
- 8031525
- FEI Number
- 6827
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1110 OYANA
- City
- SEKI CITY Gifu
- Country
- JP
Owner / Operator
- Firm Name
- KAI INDUSTRIES CO., LTD.
- Operator Number
- 8031525
- Address
- 1110 Oyana
- City
- Seki
- State
- Gifu
- Postal Code
- 5013992
- Country
- JP
US Agent
- Business Name
- KAI USA LTD.
- Contact Name
- Noritaka Sawamura
- Address
- 18600 S.W. TETON AVE.
- City
- TUALATIN
- State
- OR
- ZIP
- 97062
- Country
- US
- [email protected]
- Phone
- 503 6821966
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2003-10-07 |
Proprietary Names
TR-125/14AGF BEVEL UP, 45 DEGREE BENT 1.25x1.4 ANTI-GLARE TYPE
BKB-10AGF BEVEL UP, 45 DEGREE BENT WIDTH 1MM ANTI-GLARE TYPE
VK20 MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM
CWU-26AGF BEVEL UP, 60 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE
SK-SLU32 BEVEL UP, 45 DEGREE BENT WIDTH 3.2MM
VK-19GF MVR 19 GAUGE VITRECTOMY KNIFE dia. 1MM
SP-S15 ANGLE 15 DEGREE WIDTH 1MM THICKNESS 0.1MM
SLU-28AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM ANTI-GLARE TYPE
CCR-22AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
SLU-275AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.75MM ANTI-GLARE TYPE
SK-A30 ANGLE 30 DEGREE THICKNESS 0.1MM
VK25 MVR 25 GAUGE VITRECTOMY KNIFE dia. 0.5MM
CC24 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM
A-15F ANGLE 15 DEGREE THICKNESS 0.1MM
SLU-32AGF BEVEL UP, 45 DEGREE BENT WIDTH 3.2MM ANTI-GLARE TYPE
CC22 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM
VK-20GF MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM
RNU-41AGF BEVEL UP, 45 DEGREE BENT WIDTH 4.1MM ANTI-GLARE TYPE
RNU-51AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.1MM ANTI-GLARE TYPE
SK-CCR23 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.3MM
SLU-14AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.4MM ANTI-GLARE TYPE
SLU-18AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.8MM ANTI-GLARE TYPE
TR-12/14AGF BEVEL UP, 45 DEGREE BENT 1.2x1.4 ANTI-GLARE TYPE
SK-SLU20 MBEVEL UP, 45 DEGREE BENT WIDTH 2MM
SL28 BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM
SK-SLU30 BEVEL UP, 45 DEGREE BENT WIDTH 3MM
SK-CCR20 MDOUBLE BEVEL, 45 DEGREE BENT WIDTH 2MM
ST30 ANGLE 30 DEGREE THICKNESS 0.12MM
SK-CCR30 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM
CCR-20AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2MM ANTI-GLARE TYPE
SK-CCR18 MDOUBLE BEVEL, 45 DEGREE BENT WIDTH 1.8MM
PCT-10F STRAIGHT 1MM WIDTH THICKNESS 0.1MM
CCR-265AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.65MM ANTI-GLARE TYPE
CCR-25AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.5MM ANTI-GLARE TYPE
SK-VKB20G MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM BENT TYPE
A-0F ANGLE 0 DEGREE THICKNESS 0.1MM
SK-CCR32 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3.2MM
CC30 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM
SK-CCR28 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM
SLU-13AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.3MM ANTI-GLARE TYPE
SL275 BEVEL UP, 45 DEGREE BENT WIDTH 2.75MM
A-45F ANGLE 45 DEGREE THICKNESS 0.1MM
CC275 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.75MM
BKS-10AGF BEVEL UP, STRAIGHT WIDTH 1MM ANTI-GLARE TYPE
SL22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM
SP-U10 BEVEL UP, 45 DEGREE BENT WIDTH 1MM ANTI-GLARE TYPE
SLU-22AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
ST225 ANGLE 22.5 DEGREE THICKNESS 0.12MM
PCB-10AGF ANGLED 1MM WIDTH THICKNESS 0.1MM
SK-CPU16 BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE
SK-SLU23 BEVEL UP, 45 DEGREE BENT WIDTH 2.3MM
SK-CCR22 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM
SK-SLU24 BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM
A-225F ANGLE 22.5 DEGREE THICKNESS 0.1MM
SK-CCR24 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM
SLU-24AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM ANTI-GLARE TYPE
VK23 MVR 23 GAUGE VITRECTOMY KNIFE dia. 0.6MM
CPU-26AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE
SK-A15 ANGLE 15 DEGREE THICKNESS 0.1MM
SL24 BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM
CPU-16AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE
SP-T12 BEVEL UP, 30 DEGREE BENT 0.5x1.2 ANTI-GLARE TYPE
VKB-20GF MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM BENT TYPE
SLU-17AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.7MM ANTI-GLARE TYPE
VK-23GF MVR 23 GAUGE VITRECTOMY KNIFE dia. 0.6MM
SK-CPU22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
SLU-23AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.3MM ANTI-GLARE TYPE
A-30F ANGLE 30 DEGREE THICKNESS 0.1MM
SLU-25AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.5MM ANTI-GLARE TYPE
CCR-28AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM ANTI-GLARE TYPE
CCR-30AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM ANTI-GLARE TYPE
SLU-15AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.5MM ANTI-GLARE TYPE
CPU-22AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
SLU-285AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.85MM ANTI-GLARE TYPE
TR-15/19AGF BEVEL UP, 45 DEGREE BENT 1.5x1.9 ANTI-GLARE TYPE
SK-SLU22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM
SLU-16AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE
ST15 ANGLE 15 DEGREE THICKNESS 0.12MM
SK-SLU18 MBEVEL UP, 45 DEGREE BENT WIDTH 1.8MM
CCR-18AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 1.8MM ANTI-GLARE TYPE
SK-CPU26 BEVEL UP, 45 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE
CCR-32AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3.2MM ANTI-GLARE TYPE
CCR-24AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM ANTI-GLARE TYPE
RNU-56AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.6MM ANTI-GLARE TYPE
SL30 BEVEL UP, 45 DEGREE BENT WIDTH 3MM
RNU-52AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.2MM ANTI-GLARE TYPE
CC28 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM
SK-SLU28 BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM
SLU-265AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.65MM ANTI-GLARE TYPE
SLU-19AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.9MM ANTI-GLARE TYPE
SLU-20AGF BEVEL UP, 45 DEGREE BENT WIDTH 2MM ANTI-GLARE TYPE
SK-A225 ANGLE 22.5 DEGREE THICKNESS 0.1MM
CCR-23AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.3MM ANTI-GLARE TYPE
SLU-30AGF BEVEL UP, 45 DEGREE BENT WIDTH 3MM ANTI-GLARE TYPE
Establishment Types
Manufacture Medical Device