FDA Registration
Active
🇮🇳 India
ACL Tip C Aimer, Right
Reg #: 3010303097
·
FEI: 3010303097
·
Expires 2025
Products
1
Proprietary Names
62
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Auxein medical Private limited
- Registration Number
- 3010303097
- FEI Number
- 3010303097
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area,, HSIIDC Sonipat- 131028, Haryana, INDIA
- City
- Sonipat Haryana
- Country
- IN
Owner / Operator
- Firm Name
- Auxein Medical Pvt Ltd
- Operator Number
- 10046810
- Address
- Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonepat- 131028, Haryana, INDIA, HSIIDC Sonipat- 131028, Haryana, INDIA
- City
- Sonipat
- State
- Haryana
- Postal Code
- 131028
- Country
- IN
US Agent
- Business Name
- 510K FDA Inc.
- Contact Name
- Lee Strong
- Address
- 156 E Granada Blvd
- City
- Ormond Beach
- State
- FL
- ZIP
- 32176
- Country
- US
- [email protected]
- Phone
- 386 8466037
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2016-01-19 |
Proprietary Names
ACL Tip C Aimer, Right
Rasp, Up
Alligator Mini Grasping Forceps, Straight Jaws, Straight Shaft
PCL Femoral Aimer
Rosen Knife, Toothed Blade
Dia 2.4mm x 250 mm Passing Pin
Knot Pusher for Meniscal Repair
Hook Knife, Reverse Cutting
Diamond Rasp, 90 Degree for Meniscal Repair
Retrograde Knife, 45 Degree Angled Blade
Suture Retriever
Button Holder With Scale
Mini Grasping Forceps
Mini Scissors, Upwards Cutting
Blunt Nose Mini Basket Punch, Straight Jaws, Straight Shaft
Knot Pusher with Suture Cutter for Meniscal Repair
Mini Knife, Curve
Rotor Dia 2.7mm, 360 Degree Rotating, 110mm Working Length
Tunnel Dilator, Cannulated, Dia 9mm
Diamond Rasp, 45 Degree for Meniscal Repair
Suture Cutter/Knot Pusher With Lock, Dia 4.2mm, V-Knotch, Left Opened
Scalpel Knife
Knot Pusher
Side Cutter Mini Basket Punch, Right Side Cutting, 2.2mm
Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Left Curved Shaft
ACL Tip O Aimer
ACL Elbow Aimer
Mini Scissors, Shot, Upwards Cutting
Oval Mini Punch, Straight Jaws, Straight Shaft
Mini Rasp, Convex Jaw
ACL Tip Aimer
Rasp, Down
Side Cutter Mini Basket Punch, Left Side Cutting, 2.2mm
Mini Rasp, Concave Jaw
Straight Rasp
Tunnel Dilator, Cannulated, Dia 6mm
Needle Pusher
Switching Stick
Hook Scissors, Straight, Dia 2.7mm
PCL Tibial Aimer With O Tip
Mini Punch
DownBiter Dia 2.7mm, Downwards Cutting, 110mm Working Length
Half-Round Rasp
Oval Mini Punch, Left Jaws, Straight Shaft
Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Upbiter
Mini Knife With V - Knotch
ACL Tip C Aimer, Left
Banana Knife
Convex Rasp
Tunnel Dilator, Cannulated, Dia 8 mm
Mini Bone Curette
Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Straight Shaft
UpBiter Dia 2.7mm, Upwards Cutting, 110mm Working Length
Suture Pull Handle
3mm Spoon, Angled Tip
Tunnel Dilator, Cannulated, Dia 10mm
Tissue Grasper, Long
Suture Holder With Tensioner
Oval Mini Punch, Right Jaws, Straight Shaft
Shark Mini Grasping Forceps, Straight Jaws, Straight Shaft
Dunckbill Mini Punch Cut 1.5mm, Straight Jaws, Right curved shaft
Tunnel Dilator, Cannulated, Dia 7mm
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device