FDA Registration
Active
🇨🇳 China
Short Screw driver With Retention Hex (3.5mm) (B)
Reg #: 3026311512
·
FEI: 3026311512
·
Expires 2025
Products
1
Proprietary Names
30
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
- Registration Number
- 3026311512
- FEI Number
- 3026311512
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO.12 Jinfeng Road, West Taihu Science and Technology Industrial Park
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
- Operator Number
- 10086983
- Address
- No. 12, Jinfeng Road, West Taihu Science and Technology Industrial Park
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213149
- Country
- CN
- Correspondent
- Jing Huang
US Agent
- Business Name
- PUREVISION AI, INC.
- Contact Name
- DJ Fang
- Address
- 111 Town Square Place, Suite 1203
- City
- Jersey City
- State
- NJ
- ZIP
- 07310
- Country
- US
- [email protected]
- Phone
- 201 5035758
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-01-04 |
Proprietary Names
Short Screw driver With Retention Hex (3.5mm) (B)
Flexible Hex Driver Ball Tip (5mm/8mm) (B)
Self-Retaining Set Screw Driver
Fixed Angle Screwdriver, Crosslink Setscrew Driver,SW3.5
Handle with Quick Coupling
Multi Axial Screwdriver, Fixed Angle Reduction Screwdriver
torque-limiting screwdriver
hexagonal screwdriver
Screwdriver Shaft 3.5, hexagonal
Universal Chuck with T-Handle
Ratcheting Handle,Quick Connect, T-Handle Ratcheting ,Quick Connect, Multi Axial Reduction Screwdriver
Handle for Torque Limiter
Screwdriver, hexagonal, large, 3.5 mm
Screwdriver, hexagonal with spherical head 10 mm, cannulated
Stardriver
Dual Ended Plug Starter, T-Handle with Quick Connect
Extraction Screw for Screws 3.5mm
Handle for Torque Limiters 0.4/0.8/1.2Nm
Extraction Screw, conical, for Screws 2.7, 3.5, 4 and 4.5
Screw tap HB 6.5
Torque Limiter, 1.5Nm
Screwdriver Shaft,hexagonal, small, 2.5mm
Torque-Limiting Handle,12.5N.m
Self-Retaining Break-Off Driver
Torque Limiter, 0.8Nm
Torque Limiter 4N
Screw tap HA4.5
Extraction Screw for screws 2 and 2.4mm
Extraction Screw, conical, for Screws 1.5 and 2mm
Insertion Handle
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)