FDA UDI
In Commercial Distribution
🇺🇸 United States
ANKYRAS
DI: 08437025622016
·
Model: v4.0.4-US
·
MENTICE SPAIN S.L.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANKYRAS
- Primary DI
- 08437025622016
- Version / Model
- v4.0.4-US
- Company Name
- MENTICE SPAIN S.L.
- Labeler DUNS
- 471570274
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-26
- Public Version
- 1
- Public Version Date
- 2026-03-06
- Public Version Status
- New
- Public Device Record Key
- 6d9d0437-4acd-4fe2-bc39-43e30ab985d7
Device Characteristics
- Single Use
- No
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61486 | Surgical simulation system | A mobile computerized assembly of mains electricity (AC-powered) devices intended to collect and manipulate medical imaging [e.g., computed tomography (CT), magnetic resonance imaging (MRI)] data to create a patient-specific, virtual, three-dimensional (3-D), interactive model to enable a surgeon to simulate, rehearse, and plan a surgical procedure (e.g., cranial) prior to surgery. It includes dedicated software, and dedicated and/or off-the-shelf hardware such as a cart, a personal computer (PC), monitors, 3-D glasses, and a controller to simulate surgical devices and perform measurements. It is capable of collecting patient demographics, which may be anonymised. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437025622016 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250160 | 000 |