FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00763000164409
·
Model: 46137
·
MEDTRONIC PS MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00763000164409
- Version / Model
- 46137
- Company Name
- MEDTRONIC PS MEDICAL, INC.
- Labeler DUNS
- 089055867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 2
- Public Version Date
- 2022-10-17
- Public Version Status
- Update
- Public Device Record Key
- 1c902c72-51f5-4f77-9fc5-212510bb0955
Device Description
CLMP 46137 QUICK ATTACH POLE W/LAS
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWM | Device, monitoring, intracranial pressure | Neurology | 882.1620 | 2 |
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40893 | Laser patient positioning system | A fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000164409 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983799 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius