FDA UDI
In Commercial Distribution
🇺🇸 United States
Techno-Aide
DI: G242RDS129
·
Model: RDS-12
·
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
- G242RDS129
- Version / Model
- RDS-12
- Catalog Number
- RDS-12
- Company Name
- Techno-Aide, Inc.
- Labeler DUNS
- 843929279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-13
- Public Version
- 1
- Public Version Date
- 2023-02-21
- Public Version Status
- New
- Public Device Record Key
- df339033-fd57-4448-b2aa-980191e553fc
Device Description
UNIVERSAL PATIENT RESTRAINT STRAP
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
- 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 |
|---|---|---|---|---|
| 62482 | Limb/torso/head restraint, reusable | A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G242RDS1290 | HIBCC | Package | 1 | In Commercial Distribution | |
| Primary | G242RDS129 | HIBCC |
Customer Contacts
- Phone
- +1(615)350-7030
- [email protected]