FDA UDI
In Commercial Distribution
🇺🇸 United States
Shoulder SatPad™
DI: 00850004813089
·
Model: 1
·
Sat Pad Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Shoulder SatPad™
- Primary DI
- 00850004813089
- Version / Model
- 1
- Catalog Number
- 100008
- Company Name
- Sat Pad Inc.
- Labeler DUNS
- 081347868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-02
- Public Version
- 2
- Public Version Date
- 2019-04-12
- Public Version Status
- Update
- Public Device Record Key
- ff3ea0c0-9274-4b9f-9267-ead5f63d4343
Device Description
Shoulder Radiological Positioning Device
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 |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40900 | Radiological arm/leg positioner | A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also 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 | 00850004813089 | GS1 | ||||
| Package | 10850004813086 | GS1 | carton | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 667-225-2721
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K926416 | 000 |