FDA UDI
In Commercial Distribution
🇺🇸 United States
TruForm Annuloplasty Ring
DI: B040TRH280
·
Model: TRH-28
·
GENESEE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TruForm Annuloplasty Ring
- Primary DI
- B040TRH280
- Version / Model
- TRH-28
- Company Name
- GENESEE BIOMEDICAL, INC.
- Labeler DUNS
- 939872651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-04
- Public Version
- 1
- Public Version Date
- 2024-12-12
- Public Version Status
- New
- Public Device Record Key
- 61f89427-3b9c-4343-b7f6-afef7f32d355
Device Description
Annuloplasty Ring
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KRH | Ring, Annuloplasty | Cardiovascular | 870.3800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66338 | Mitral/tricuspid annuloplasty ring, open-surgery | A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B040TRH28 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | B040TRH280 | HIBCC |
Customer Contacts
- Phone
- 800 786-4890
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202253 | 000 |