FDA UDI
In Commercial Distribution
🇺🇸 United States
Inion® Universal instruments
DI: 06438408002175
·
Model: 1
·
Inion Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Inion® Universal instruments
- Primary DI
- 06438408002175
- Version / Model
- 1
- Catalog Number
- ACC-9840
- Company Name
- Inion Oy
- Labeler DUNS
- 367994657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-08
- Public Version
- 1
- Public Version Date
- 2020-05-18
- Public Version Status
- New
- Public Device Record Key
- d7871f8c-f1ec-497b-a741-4e0e934e0602
Device Description
Inion Thermo+ (water bath 110 V + US plug)
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IRQ | UNIT, HEATING, POWERED | Physical Medicine | 890.5950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17526 | Thermoplastic-moulding water bath | A mains electricity (AC-powered) water bath specifically designed for the warming/heating of mouldable plastic materials (thermoplastics) used to create body positioning and body fixation devices, splints, and orthotic devices. It will typically consist of a large water holder (pan) that is temperature-regulated from, e.g., room temperature to 100? Celsius, temperature controls, thermometer/thermostats, timer. Sheets or pre-cut pieces of thermoplastic materials are placed into the water with the temperature set according to the material specifications so that these become soft enough to mould to the required shape. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M224ACC98409 | HIBCC | ||||
| Primary | 06438408002175 | GS1 |