BOVIE®
- Primary DI
- 00607151012168
- Brand
- BOVIE®
- Company
- BOVIE MEDICAL CORPORATION
- Model
- H10108
- Catalog number
- H10108
- Device description
- H-TYPE BLUNT TIP DISPOSABLE DERMAL ELECTRODE, STERILE
- Published
- 2017-06-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10607151012165 | Package | GS1 | 50 | In Commercial Distribution |
| 00607151012168 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10607151012165 | 10607151012165 | ||
| 00607151012168 | 00607151012168 | 607151012168 | 0607151012168 |
GMDN Terms
| Term | Definition |
|---|---|
| Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Atmospheric Pressure | 10 Percent (%) Relative Humidity | 75 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 10 Degrees Fahrenheit | 30 Degrees Fahrenheit |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 079940465
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10607151006737 | Bovie | A827BP | A827BP | 2017-02-14 |
| 10607151011526 | Bovie | AD-330-A8 | AD-330-A8 | 2017-03-30 |
| 10607151011601 | Bovie | AD-770-A8 | AD-770-A8 | 2017-03-30 |
| 10607151011649 | Bovie | AD-770R-A8 | AD-770R-A8 | 2017-03-30 |
| 10607151011694 | Bovie | A5 | A5 | 2017-03-30 |
| 10607151012028 | Bovie | AD-330-A5 | AD-330-A5 | 2017-03-30 |
| 10607151012042 | Bovie | AD-330R-A5 | AD-330R-A5 | 2017-03-30 |
| 10607151012073 | Bovie | AD-770-A5 | AD-770-A5 | 2017-03-30 |
| 10607151012097 | Bovie | AD-770R-A5 | AD-770R-A5 | 2017-03-30 |
| 10607151001114 | Bovie | IDS-200 | IDS-200 | 2016-10-13 |
| 10607151001121 | Bovie | IDS-300 | IDS-300 | 2016-10-13 |
| 10607151002784 | Bovie | A2250-LOANER | A2250-LOANER | 2016-10-13 |
| 10607151002791 | Bovie | IDS-300-LOANER | IDS-300-LOANER | 2016-10-13 |
| 10607151002807 | Bovie | IDS-200-LOANER | IDS-200-LOANER | 2016-10-13 |
| 10607151003101 | Bovie | A3250-LOANER | A3250-LOANER | 2016-10-13 |
| 10607151004726 | Bovie | IDS-400 | IDS-400 | 2016-10-13 |
| 10607151005327 | Bovie | GS100 | GS100 | 2016-10-13 |
| 10607151005334 | Bovie | A940 | A940 | 2016-10-13 |
| 10607151005365 | Bovie | A940-LOANER | A940-LOANER | 2016-10-13 |
| 10607151005525 | Bovie | A2250-DEMO | A2250-DEMO | 2016-10-13 |
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| 00887482178355 | Bovie | SYMMETRY SURGICAL INC. | HGI | 2024-08-27 |