FDA UDI
In Commercial Distribution
🇺🇸 United States
Ventris SIgnal™
DI: 06438408009730
·
Model: 1
·
Inion Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ventris SIgnal™
- Primary DI
- 06438408009730
- Version / Model
- 1
- Catalog Number
- SGN-1500
- Company Name
- Inion Oy
- Labeler DUNS
- 367994657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-03
- Public Version
- 1
- Public Version Date
- 2020-03-11
- Public Version Status
- New
- Public Device Record Key
- 5c951c6f-43aa-4ff1-80a0-bc4afec87379
Device Description
Morsels 1.5 cc / 1.5 ml
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
- 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 |
|---|---|---|---|---|
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16966 | Synthetic bone graft | An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438408009730 | GS1 |