Olympus
- Primary DI
- 04042761000116
- Brand
- Olympus
- Company
- OLYMPUS Winter & Ibe GmbH
- Model
- 00115
- Catalog number
- 00115
- Device description
- HF-electrode, needle, 7 Fr., flexible
- Published
- 2016-09-21
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
xx.xxProduct Codes
| Code | Name |
|---|---|
| GCP | Endoscope, Ac-Powered And Accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GCP | Endoscope, Ac-Powered And Accessories | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04042761000116 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04042761000116 | 04042761000116 | 4042761000116 |
GMDN Terms
| Term | Definition |
|---|---|
| Endoscopic electrosurgical electrode, monopolar, reusable | An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| +1(800)401-1086 | xx@xx.xx |
Regulatory Flags
- DUNS number
- 316957240
- 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
- false
- 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 |
|---|---|---|---|---|
| 04042761005722 | Olympus | A3764A | A3764A | 2016-09-21 |
| 04042761005739 | Olympus | A3765A | A3765A | 2016-09-21 |
| 04042761077729 | Olympus | WA2P400A | WA2P400A | 2016-09-21 |
| 04042761002981 | Olympus | A2250 | A2250 | 2016-09-21 |
| 04042761009805 | Olympus | A60210A | A60210A | 2016-09-21 |
| 04042761009812 | Olympus | A60211A | A60211A | 2016-09-21 |
| 04042761010214 | Olympus | A64310A | A64310A | 2016-09-21 |
| 04042761010283 | Olympus | A64610A | A64610A | 2016-09-21 |
| 04042761010290 | Olympus | A64610L | A64610L | 2016-09-21 |
| 04042761010306 | Olympus | A64620A | A64620A | 2016-09-21 |
| 04042761010351 | Olympus | A64820L | A64820L | 2016-09-21 |
| 04042761010436 | Olympus | A66070A | A66070A | 2016-09-21 |
| 04042761010610 | Olympus | A70959A | A70959A | 2016-09-21 |
| 04042761011068 | Olympus | A7517 | A7517 | 2016-09-21 |
| 04042761011082 | Olympus | A7519 | A7519 | 2016-09-21 |
| 04042761020381 | Olympus | A20975A | A20975A | 2016-09-21 |
| 04042761021142 | Olympus | A22073A | A22073A | 2016-09-21 |
| 04042761021173 | Olympus | A22083A | A22083A | 2016-09-21 |
| 04042761021203 | Olympus | A22087A | A22087A | 2016-09-21 |
| 04042761023054 | Olympus | A37000A | A37000A | 2016-09-21 |
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