FDA UDI
In Commercial Distribution
🇺🇸 United States
Techno-Aide
DI: G242YX16MR9
·
Model: YX16-MR
·
Techno-Aide, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Techno-Aide
- Primary DI
- G242YX16MR9
- Version / Model
- YX16-MR
- Catalog Number
- YX16-MR
- Company Name
- Techno-Aide, Inc.
- Labeler DUNS
- 843929279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-05
- Public Version
- 1
- Public Version Date
- 2025-09-15
- Public Version Status
- New
- Public Device Record Key
- 6995b59c-eb79-49f5-8072-1d47fbf9b22d
Device Description
MR Conditional Closed Cell 45° Wedge Sponge [30" x 9" x 9"]
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NAB | Gauze / sponge,nonresorbable for external use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61131 | Radiological general body-part positioner | A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad 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 |
|---|---|---|---|---|---|---|
| Package | G242YX16MR90 | HIBCC | Package | 1 | In Commercial Distribution | |
| Primary | G242YX16MR9 | HIBCC |
Customer Contacts
- Phone
- +1(615)350-7030
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 1