FDA UDI
In Commercial Distribution
🇺🇸 United States
SyncAR SNAP
DI: 00860003884102
·
Model: SyncAR
·
SURGICAL THEATER LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SyncAR SNAP
- Primary DI
- 00860003884102
- Version / Model
- SyncAR
- Company Name
- SURGICAL THEATER LLC
- Labeler DUNS
- 071341647
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-01
- Public Version
- 2
- Public Version Date
- 2023-06-26
- Public Version Status
- Update
- Public Device Record Key
- 8c063ec6-0df5-432f-9607-5ddbd39f0319
Device Description
SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61496 | Surgical planning/navigation-enhancement system | A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. 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 | 00860003884102 | GS1 |
Customer Contacts
- Phone
- 330-472-6520
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160584 | 000 |