FDA Registration
Active
🇮🇳 India
REDISORB® FAST PRO; MERISOFT CHROMIC/REDIGUT® CHROMIC PRO; MERISOFT
Reg #: 3018052045
·
FEI: 3018052045
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- AKSHAR GAMMA STERILES LLP
- Registration Number
- 3018052045
- FEI Number
- 3018052045
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST,
- City
- THANE Maharashtra
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K982646
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, Nonabsorbable, Synthetic, Polypropylene | GAW | 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, 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 | GAO | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
Proprietary Names
REDISORB® FAST PRO; MERISOFT CHROMIC/REDIGUT® CHROMIC PRO; MERISOFT
PLAIN/REDIGUT® PLAIN PRO; REDISILK® PRO; REDILON® PRO; REDIBOND® PRO
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)