FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermasplint
DI: 00645724001089
·
Model: SP-1501-220V
·
Whitehall Manufacturing Co
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Thermasplint
- Primary DI
- 00645724001089
- Version / Model
- SP-1501-220V
- Catalog Number
- SP-1501-220V
- Company Name
- Whitehall Manufacturing Co
- Labeler DUNS
- 008312423
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 1
- Public Version Date
- 2018-08-13
- Public Version Status
- New
- Public Device Record Key
- 9ead6ce8-9534-493c-b425-e43d8115dc49
Device Description
Forma-Splint-SP1501 with 220V
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00645724001089 | GS1 |
Customer Contacts
- Phone
- (800) 782-7706
- [email protected]