FDA Registration
Active
🇺🇸 United States
Curity AMD Antimicrobial Woven Sponge, 2x2
Reg #: 3012100095
·
FEI: 3012100095
·
Expires 2025
Products
1
Proprietary Names
2
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
Regulatory Submissions
- 510(k) Number
- K011941
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, Drug | FRO | Class U | Unknown | No | 2021-11-29 |
Proprietary Names
Curity AMD Antimicrobial Woven Sponge, 2x2
Curity AMD Antimicrobial Woven Sponge, 4x4
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198