FDA UDI
In Commercial Distribution
🇺🇸 United States
Navio
DI: 20885556628908
·
Model: PFSDV0016
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
9
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Basic Information
- Brand Name
- Navio
- Primary DI
- 20885556628908
- Version / Model
- PFSDV0016
- Catalog Number
- PFSDV0016
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2024-03-22
- Public Version Status
- Update
- Public Device Record Key
- cf81833c-7084-4f84-b5bd-b2001dae6c33
Device Description
Navio Flat Markers
Device Characteristics
- Single Use
- Yes
- 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
- 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 | 20885556628908 | GS1 | ||||
| Unit of Use | 00885556628904 | GS1 | ||||
| Package | 30885556628905 | GS1 | BX | 2 | In Commercial Distribution | |
| Package | 40885556628902 | GS1 | CAS | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]