FDA UDI
In Commercial Distribution
🇺🇸 United States
EnVisio System
DI: 00851674008553
·
Model: ENVISIO-SYS
·
Elucent Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EnVisio System
- Primary DI
- 00851674008553
- Version / Model
- ENVISIO-SYS
- Company Name
- Elucent Medical, Inc.
- Labeler DUNS
- 079322481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-04
- Public Version
- 2
- Public Version Date
- 2025-11-21
- Public Version Status
- Update
- Public Device Record Key
- c12f0e25-b93c-43be-8bdf-8b2e20cc4fa2
Device Description
EnVisio System including the following components: SmartSurface, foot pedal and heads-up display
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67652 | Electromagnetic device tracking system spatial marker, powered | An electrically-powered, noninvasive component of an electromagnetic device tracking system intended to provide a fixed reference point for the electromagnetic (EM) tracking of an instrument during a surgically-invasive procedure. It is designed to be attached to a surgical instrument (e.g., electrosurgical handpiece) and emits a unique EM signal when exposed to an EM field, which can be detected and traced by the system. A disposable calibrator may be supplied with the marker. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851674008553 | GS1 |
Customer Contacts
- Phone
- 844-417-1700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183400 | 000 |