FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioprogressive
DI: 00885797094964
·
Model: E00818
·
Rmo, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- Bioprogressive
- Primary DI
- 00885797094964
- Version / Model
- E00818
- Company Name
- Rmo, Inc.
- Labeler DUNS
- 007058183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-08-19
- Public Version
- 1
- Public Version Date
- 2024-08-27
- Public Version Status
- New
- Public Device Record Key
- e05facd3-b3dc-4218-936f-85a38c124857
Device Description
BIOPRO DBL DELTA SECT MAX RT
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ECO | Spring, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31797 | Orthodontic spring | A dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00000008857972 | GS1 | ||||
| Primary | 00885797094964 | GS1 |