FDA UDI
In Commercial Distribution
🇺🇸 United States
PeriBeam® Pericardial Membrane
DI: 04589795950241
·
Model: P-090-1010
·
TAMABIO CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PeriBeam® Pericardial Membrane
- Primary DI
- 04589795950241
- Version / Model
- P-090-1010
- Company Name
- TAMABIO CO., LTD.
- Labeler DUNS
- 693002116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-17
- Public Version
- 1
- Public Version Date
- 2026-03-25
- Public Version Status
- New
- Public Device Record Key
- 85c00988-1fd6-4a0e-92f0-7dfda5420a80
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36182 | Pericardium prosthesis | An implantable synthetic material intended to be used in the repair of the pericardium (the double membranous, cone-shaped fibroserous sac enclosing the heart and the roots of the great blood vessels). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04589795950241 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240775 | 000 |