FDA UDI
In Commercial Distribution
🇺🇸 United States
XVS MARKERS WITH C-LINK KIT 10 SETS PACK
DI: 17290113781044
·
Model: ASP07059
·
AUGMEDICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- XVS MARKERS WITH C-LINK KIT 10 SETS PACK
- Primary DI
- 17290113781044
- Version / Model
- ASP07059
- Company Name
- AUGMEDICS LTD
- Labeler DUNS
- 600325755
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-24
- Public Version
- 2
- Public Version Date
- 2026-02-13
- Public Version Status
- Update
- Public Device Record Key
- ed604207-3458-49ac-b2c1-f1d664e1c5bf
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| SBF | Orthopedic Augmented Reality | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45199 | Multi-purpose stereotactic surgery system | An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290113781041 | GS1 | Shipping Box | 10 | Not in Commercial Distribution | 2024-10-24 |
| Primary | 17290113781044 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241481 | 000 |