FDA UDI
In Commercial Distribution
🇺🇸 United States
iCAST H&S Micro Head Double with support band 4mm
DI: 09120074393226
·
Model: P10107-322
·
IT-V Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- iCAST H&S Micro Head Double with support band 4mm
- Primary DI
- 09120074393226
- Version / Model
- P10107-322
- Company Name
- IT-V Medizintechnik GmbH
- Labeler DUNS
- 300005408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 7
- Public Version Date
- 2022-02-14
- Public Version Status
- Update
- Public Device Record Key
- 99c5d85b-ad5a-4d29-8f97-76e07b85d018
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40902 | Radiological whole-body positioner | A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120074393226 | GS1 | ||||
| Unit of Use | 09120074390225 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081218 | 000 |