OT EQUATOR TITANIUM ABUTMENT
- Primary DI
- 08059224138480
- Brand
- OT EQUATOR TITANIUM ABUTMENT
- Company
- RHEIN 83 SRL
- Model
- OT EQUATOR BIO VENT ø 4,5 h.3
- Catalog number
- 030BV453
- 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.
- Published
- 2021-02-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NHA | Abutment, Implant, Dental, Endosseous |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D821OTEQUATOR030BV453 | Previous | HIBCC | 0 | |
| 08059224138480 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08059224138480 | 08059224138480 | 8059224138480 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 439240722
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08059224094229 | OT EQUATOR TITANIUM ABUTMENT | OT EQUATOR XIVE TG h.3 | 230XIVTG3 | 2026-02-10 |
| 08059224115801 | PLUS | PLUS CAP EXTRACTOR-INSERTER | 488EIP | 2026-02-10 |
| 08059224127798 | OT EQUATOR | OT EQUATOR CLEAR CAP #100 | CN051-100 | 2026-02-10 |
| 08059224129044 | PLUS | PINK CAP PLUS #50 | CN087-50 | 2026-02-10 |
| 08059224129099 | PLUS | YELLOW CAP PLUS #50 | CN088-50 | 2026-02-10 |
| 08059224129143 | PLUS | VIOLET CAP PLUS #50 | CN089-50 | 2026-02-10 |
| 08059224133041 | OT EQUATOR | PINK PROTECTIVE DISK #100 | DPR-100 | 2026-02-10 |
| 08059224133058 | OT EQUATOR | PINK PROTECTIVE DISK #50 | DPR-50 | 2026-02-10 |
| 08059224134260 | OT EQUATOR | SMART BOX OT EQUATOR #50 | SBE-50 | 2026-02-10 |
| 08059224140148 | OT EQUATOR | LABORATORY ANALOGS 50 u. | AAE-50 | 2026-02-10 |
| 08059224167497 | PLUS | Transfer Heli-Loc open | 044CAIP-HE | 2026-02-10 |
| 08059224167503 | PLUS | Laboratory set Standard (with pin) | 192CPC-HE | 2026-02-10 |
| 08059224167510 | PLUS | Laboratory set Extended (without pin) | 192CPS-HE | 2026-02-10 |
| 08059224167527 | OT EQUATOR | Extraction/insertion tool for caps | 488EIP-HE | 2026-02-10 |
| 08059224167534 | PLUS | Cap without pin yellow (0,6kg / 1,32lbs) | 140CPG-HE | 2026-02-10 |
| 08059224167541 | PLUS | Cap without pin black (lab use) | 140CPN-HE | 2026-02-10 |
| 08059224167558 | PLUS | Cap without pin pink (0,8kg / 1,76lbs) | 140CPP-HE | 2026-02-10 |
| 08059224167565 | PLUS | Cap with pin yellow (0,7kg / 1,54lbs) | 140CPPG-HE | 2026-02-10 |
| 08059224167572 | PLUS | Cap with pin black (lab use) | 140CPPN-HE | 2026-02-10 |
| 08059224167589 | PLUS | Cap with pin pink (0,9kg / 1,98lbs) | 140CPPP-HE | 2026-02-10 |
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