FDA UDI
In Commercial Distribution
🇺🇸 United States
Techno-Aide
DI: G242SB03RDBKMR9
·
Model: SB-03R-DBK-MR
·
Techno-Aide, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Techno-Aide
- Primary DI
- G242SB03RDBKMR9
- Version / Model
- SB-03R-DBK-MR
- Catalog Number
- SB-03R-DBK-MR
- Company Name
- Techno-Aide, Inc.
- Labeler DUNS
- 843929279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-09
- Public Version
- 1
- Public Version Date
- 2025-09-17
- Public Version Status
- New
- Public Device Record Key
- 5b16e659-bca8-43d4-b636-4c02aef2d417
Device Description
MR Conditonal Rectangular Sandbag: 3LB (5"x9") [Black]
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 |
|---|---|---|---|---|
| CCX | SUPPORT, PATIENT POSITION | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62663 | Traction weight | A device in the form of a filled bag intended to be used with a system of rope and pulleys, or a bed traction system, to apply traction forces by means of gravity during medical procedures (e.g., orthopaedic surgery, physical therapy). It is typically filled with sand or steel shot, and may include hangers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G242SB03RDBKMR90 | HIBCC | Package | 1 | In Commercial Distribution | |
| Primary | G242SB03RDBKMR9 | HIBCC |
Customer Contacts
- Phone
- +1(615)350-7030
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 1