FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 07613327551938
·
Model: 6002-710-050
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 07613327551938
- Version / Model
- 6002-710-050
- Catalog Number
- 6002-710-050
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-26
- Public Version
- 3
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 0d4bf0a3-686d-4ec0-943e-609002d1b7c1
Device Description
Flat Disc Stick-On Fiducials
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 61407 | Surgical optical-tracking spatial marker, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327551939 | GS1 | pack | 8 | In Commercial Distribution | |
| Primary | 07613327551938 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- FRAGILE
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius