FDA UDI
In Commercial Distribution
🇺🇸 United States
OT EQUATOR TITANIUM ABUTMENT
DI: 08059224138480
·
Model: OT EQUATOR BIO VENT ø 4,5 h.3
·
RHEIN 83 SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OT EQUATOR TITANIUM ABUTMENT
- Primary DI
- 08059224138480
- Version / Model
- OT EQUATOR BIO VENT ø 4,5 h.3
- Catalog Number
- 030BV453
- Company Name
- RHEIN 83 SRL
- Labeler DUNS
- 439240722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-26
- Public Version
- 1
- Public Version Date
- 2021-03-08
- Public Version Status
- New
- Public Device Record Key
- 1c87407a-1064-4a5b-aee4-f761e158bad2
Device Description
DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights.
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
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47789 | Spark-gap orthopaedic extracorporeal shock wave therapy system | A mobile assembly of devices designed to provide spark-gap-generated orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a generator with two submerged electrodes that produce spark-gap (electrohydraulic) energy, at selected impulse frequencies, transmitted in reflector-focused waves to a target area on the patient's body surface via a water-filled membrane (e.g., latex) held against the target area during treatment. It is used to treat disorders such as patellar tendonitis, soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), and/or non-union fractures of bones. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08059224138480 | GS1 | ||||
| Previous | D821OTEQUATOR030BV453 | HIBCC |