Surgical Direct
- Primary DI
- B382SD7720520060
- Brand
- Surgical Direct
- Company
- Surgical Direct, Inc.
- Model
- SD77205-2006
- Catalog number
- SD77205-2006
- Device description
- 5mm 32cm Kleppinger Bipolar Forceps, Flat Tip
- Published
- 2022-11-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HIN | COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B382SD7720520060 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Endoscopic electrosurgical handpiece/electrode, bipolar, reusable | An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 124367223
- 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
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|---|
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| 06976860690382 | ClearVision | OriGyn Medical Technology (Hangzhou) Co., Ltd. | HIN | 2024-09-23 |
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| 06976860690405 | ClearVision | OriGyn Medical Technology (Hangzhou) Co., Ltd. | HIN | 2024-09-23 |
| 00887482128596 | Symmetry Surgical | SYMMETRY SURGICAL INC. | HIN | 2024-09-09 |
| 00887482128602 | Symmetry Surgical | SYMMETRY SURGICAL INC. | HIN | 2024-09-09 |
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| 00190776214319 | Millennium | Avalign Technologies, Inc. | HIN | 2022-12-12 |
| B382SD771056760 | Surgical Direct | Surgical Direct, Inc. | HIN | 2022-11-30 |
| B382SD77205200200 | Surgical Direct | Surgical Direct, Inc. | HIN | 2022-11-30 |
| B382SD800340130 | Surgical Direct | Surgical Direct, Inc. | HIN | 2022-11-30 |
| B382SD8003401390 | Surgical Direct | Surgical Direct, Inc. | HIN | 2022-11-30 |
| B382SD10510040 | Surgical Direct | Surgical Direct, Inc. | HIN | 2022-11-23 |
| B382SD1051004H0 | Surgical Direct | Surgical Direct, Inc. | HIN | 2022-11-23 |
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