FDA UDI
In Commercial Distribution
🇺🇸 United States
Navbit Sprint_Lateral
DI: 09369998142903
·
Model: HBS-00-002
·
NAVBIT PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Navbit Sprint_Lateral
- Primary DI
- 09369998142903
- Version / Model
- HBS-00-002
- Company Name
- NAVBIT PTY LTD
- Labeler DUNS
- 744162019
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-27
- Public Version
- 1
- Public Version Date
- 2021-05-05
- Public Version Status
- New
- Public Device Record Key
- ed0fae7c-9998-488d-b262-b22cebef7e5b
Device Description
Cup Alignment Technology for Hip Replacement
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 45200 | Orthopaedic stereotactic surgery system | An 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 orthopaedic surgery. 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 |
|---|---|---|---|---|---|---|
| Primary | 09369998142903 | GS1 |
Customer Contacts
- Phone
- +61433482325
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200376 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Inch |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Transport Temp. -29-60 Deg. Celsius and 15-90% RH