FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Therma-Ti
DI: 00190746028076
·
Model: 858-503IDSPW
·
AMERICAN ORTHODONTICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Therma-Ti
- Primary DI
- 00190746028076
- Version / Model
- 858-503IDSPW
- Catalog Number
- 858-503IDSPW
- Company Name
- AMERICAN ORTHODONTICS CORPORATION
- Labeler DUNS
- 044668515
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-24
- Public Version
- 5
- Public Version Date
- 2020-06-18
- Public Version Status
- Update
- Public Device Record Key
- f7b93bf2-14de-43ed-b076-ae00220c215c
- Distribution End Date
- 2018-06-20
Device Description
WIRE THERMA TI FORM III UPPER 013 W/DIMPLE IND /PK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DZC | WIRE, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16204 | Orthodontic wire | A thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190746028076 | GS1 |
Customer Contacts
- Phone
- +1(800)558-7687
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- High: 38 Degrees Celsius