FDA UDI
In Commercial Distribution
🇺🇸 United States
SkyWalker
DI: 00850030914354
·
Model: NB-10202
·
Microport Navibot International LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SkyWalker
- Primary DI
- 00850030914354
- Version / Model
- NB-10202
- Catalog Number
- NB-10202
- Company Name
- Microport Navibot International LLC
- Labeler DUNS
- 118104014
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-24
- Public Version
- 1
- Public Version Date
- 2025-05-02
- Public Version Status
- New
- Public Device Record Key
- faf94d2b-26a8-4e06-aeda-f64af52c8c11
Device Description
Paper Marker Sterile 32 Pack
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65388 | Surgical optical-tracking spatial marker, single-use | A non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850030914354 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213873 | 000 |