FDA UDI
In Commercial Distribution
🇺🇸 United States
SPINEMASK
DI: 37613252731437
·
Model: 6002-390-000
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- SPINEMASK
- Primary DI
- 37613252731437
- Version / Model
- 6002-390-000
- Catalog Number
- 6002-390-000
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2021-02-18
- Public Version Status
- Update
- Public Device Record Key
- fe333605-6c58-40f7-9fe4-44889025f238
Device Description
SPINEMASK (TM) TRACKER
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
- No
- 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 |
|---|---|---|---|---|
| 47020 | Imaging lesion localization marker, external, single-use | A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 37613252731437 | GS1 | ||||
| Unit of Use | 07613252731436 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 25.0 | Millimeter | |
| Width | 255.0 | Millimeter | |
| Length | 377.0 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- 50-106KPA
- Type
- Special Storage Condition, Specify
- Special Conditions
- Transport 10-90 Percent
- Type
- Special Storage Condition, Specify
- Special Conditions
- -20 Degrees Celsius to 70 Degrees Celsius