FDA UDI
In Commercial Distribution
🇺🇸 United States
Head Frame Cranial Screws, Short
DI: 10858086006273
·
Model: P1008070003
·
VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
Basic Information
- Brand Name
- Head Frame Cranial Screws, Short
- Primary DI
- 10858086006273
- Version / Model
- P1008070003
- Company Name
- VARIAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 009120817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2021-01-16
- Public Version
- 1
- Public Version Date
- 2021-01-25
- Public Version Status
- New
- Public Device Record Key
- 1fe44268-20bf-4df5-b782-f626f93f2102
Device Description
Pouch of 2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35361 | Stereotactic radiosurgical invasive head frame | A device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30858086006277 | GS1 | Case | 10 | In Commercial Distribution | |
| Package | 20858086006270 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 10858086006273 | GS1 | ||||
| Unit of Use | 00858086006276 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180586 | 000 |