FDA Registration
Active
🇺🇸 United States
KOLLSUT INTERNATIONAL INC
Reg #: 3005953126
·
FEI: 3005953126
·
Expires 2026
Products
11
Proprietary Names
15
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- KOLLSUT INTERNATIONAL INC
- Registration Number
- 3005953126
- FEI Number
- 3005953126
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1763 NE 162nd St
- City
- North Miami Beach
- State
- FL
- ZIP
- 33162
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042287
Owner / Operator
- Firm Name
- KOLLSUT INTERNATIONAL INC
- Operator Number
- 9093450
- Address
- 1763 NE 162nd Street, --
- City
- North Miami Beach
- State
- FL
- Postal Code
- 33162
- Country
- US
- Correspondent
- ARKADY TEPLITSKY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2023-11-24 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2016-07-31 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2016-07-31 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2018-06-20 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2007-01-17 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2016-07-31 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2016-07-31 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2016-07-31 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2016-07-31 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2020-02-26 |
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2011-12-07 |
Proprietary Names
catgut suture
Rastoro
GILZA
KOFLON
Rastoro Fast
SIETKA
RESTEL
PIDILEN
MOLYLON
SILDA
RADIK
RIKID
BIOLIFT
KOLITON
SIMFRA
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device