FDA Registration
Active
🇮🇳 India
AKSHAR GAMMA STERILES LLP
Reg #: 3018052045
·
FEI: 3018052045
·
Expires 2026
Products
18
Proprietary Names
11
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- AKSHAR GAMMA STERILES LLP
- Registration Number
- 3018052045
- FEI Number
- 3018052045
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST,
- City
- THANE Maharashtra
- Country
- IN
Owner / Operator
- Firm Name
- AKSHAR GAMMA STERILES LLP
- Operator Number
- 10084053
- Address
- PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST,
- City
- THANE
- State
- Maharashtra
- Postal Code
- 421506
- Country
- IN
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Nonabsorable, Ophthalmic | HMN | Class 3 | Unknown | No | 2022-12-28 |
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Nonabsorbable | GAO | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2022-01-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-12-29 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2022-12-29 |
Proprietary Names
PLAIN/REDIGUT® PLAIN PRO; REDISILK® PRO; REDILON® PRO; REDIBOND® PRO
REDISORB® FAST PRO; MERISOFT CHROMIC/REDIGUT® CHROMIC PRO; MERISOFT
Mirus Ligating Clip
Filamide
Latitude Hip Replacement System (Acetabular Cup System)
MIRUS Linear Stapler (Gun)
Latitude Hip Replacement System (Triad Acetabular Cup System & Proximally coated un-cemented femoral stem)
MITSU FST
FILASILK; FILAMIDE; MERICRON
MERISTEEL
Opulent TiNbN Coated Knee
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)