FDA UDI
In Commercial Distribution
🇺🇸 United States
Tutomesh™ bovine pericardium10x16 cm
DI: 04041543311952
·
Model: BP3016
·
Tutogen Medical GmbH
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tutomesh™ bovine pericardium10x16 cm
- Primary DI
- 04041543311952
- Version / Model
- BP3016
- Catalog Number
- BP3016
- Company Name
- Tutogen Medical GmbH
- Labeler DUNS
- 343337499
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-14
- Public Version
- 7
- Public Version Date
- 2023-10-19
- Public Version Status
- Update
- Public Device Record Key
- 0e0b05e2-3a2b-462a-9ee4-c3532ed312bf
Device Description
Bovine Pericardium 10 x 16 cm
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 |
|---|---|---|---|---|
| DXZ | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | Cardiovascular | 870.3470 | 2 |
| PAJ | Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed | General, Plastic Surgery | 878.3300 | 2 |
| FTM | Mesh, surgical | General, Plastic Surgery | 878.3300 | 2 |
| OXH | Mesh, surgical, collagen, plastic and reconstructive surgery | 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 | 04041543311952 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081538 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius