FDA Registration
Active
🇺🇸 United States
DynaSorb Super Absorbent Dressing Non-Adherent, Super Absorbent Dressing 6x6
Reg #: 3012100095
·
FEI: 3012100095
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORGANOGENESIS INC.
- Registration Number
- 3012100095
- FEI Number
- 3012100095
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12495 34th Street North, Suite D
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33716
- Country
- US
Owner / Operator
- Firm Name
- Organogenesis Inc.
- Operator Number
- 9008375
- Address
- 150 Dan Road, --
- City
- Canton
- State
- MA
- Postal Code
- 02021
- Country
- US
- Correspondent
- Patrick R Bilbo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2022-01-12 |
Proprietary Names
DynaSorb Super Absorbent Dressing Non-Adherent, Super Absorbent Dressing 6x6
DynaSorb Super Absorbent Dressing Non-Adherent, Super Absorbent Dressing 4x4
DynaGinate Calcium Alginate Dressing 2"x2"
CuraFoam Foam Dressing 2"x2"
DynaGinate Calcium Alginate Dressing 4"x4"
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198