FDA UDI
In Commercial Distribution
🇺🇸 United States
Ortho Technology
DI: 00190730084835
·
Model: OT-2118-SSD
·
ORTHO TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ortho Technology
- Primary DI
- 00190730084835
- Version / Model
- OT-2118-SSD
- Company Name
- ORTHO TECHNOLOGY, INC.
- Labeler DUNS
- 781772017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-18
- Public Version
- 1
- Public Version Date
- 2024-09-26
- Public Version Status
- New
- Public Device Record Key
- 2f78acaa-a46d-47ec-85f4-a9e8daca32c2
Device Description
DLR-Bracket Height Gage Alum018
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| EIL | GAUGE, DEPTH, INSTRUMENT, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31799 | Orthodontic appliance dimension gauge | A dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190730084835 | GS1 |