FDA UDI
In Commercial Distribution
🇺🇸 United States
Fortiva™ Porcine Dermis
DI: 04041543312072
·
Model: PD2035
·
Tutogen Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fortiva™ Porcine Dermis
- Primary DI
- 04041543312072
- Version / Model
- PD2035
- Catalog Number
- PD2035
- Company Name
- Tutogen Medical GmbH
- Labeler DUNS
- 343337499
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 6
- Public Version Date
- 2023-10-19
- Public Version Status
- Update
- Public Device Record Key
- 9bc3be0c-a4f2-4a3a-a0b7-4e1552900aa8
Device Description
Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue that has been processed and terminally sterilized via gamma irradiation. The surgical mesh device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with patient’s tissue. The sterile device is supplied pre-hydrated in water and is provided in various sizes. The device is ready for immediate use without extra preparation (i.e., no rinsing, no s
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTM | Mesh, surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60907 | Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial | A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04041543312072 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20x35cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius