Surgical Direct
- Primary DI
- B382SD1551040
- Brand
- Surgical Direct
- Company
- Surgical Direct, Inc.
- Model
- SD155104
- Catalog number
- SD155104
- Device description
- Graves Vaginal Speculum, X-Large, with Smoke Evacuation Tube, Insulated
- Published
- 2022-11-23
- 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 |
|---|
| HDL | RETRACTOR, VAGINAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B382SD1551040 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Vaginal speculum, reusable | A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. 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
- true
- 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
Other Devices Sharing Product Codes
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|---|
| 00198506089039 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2026-03-03 |
| 00198506089046 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2026-03-03 |
| 00198506088797 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2026-02-25 |
| 00198506088827 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2026-02-25 |
| 00198506087240 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2025-12-18 |
| 00190776409364 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-28 |
| 00190776414535 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414542 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414566 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414580 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414597 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414603 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414627 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414634 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00190776414641 | Millennium | Avalign Technologies, Inc. | HDL | 2025-08-15 |
| 00194613033224 | MSI Precision Specialty Instruments | Med Saver, Inc. | HDL | 2025-08-01 |
| 00194613065737 | MSI Precision Specialty Instruments | Med Saver, Inc. | HDL | 2025-08-01 |
| 00194613117894 | MSI Precision Specialty Instruments | Med Saver, Inc. | HDL | 2025-08-01 |
| 00194613124205 | MSI Precision Specialty Instruments | Med Saver, Inc. | HDL | 2025-08-01 |
| 00190776406677 | Millennium | Avalign Technologies, Inc. | HDL | 2025-07-23 |
| 00190776394622 | Millennium | Avalign Technologies, Inc. | HDL | 2025-05-07 |
| 00190776394639 | Millennium | Avalign Technologies, Inc. | HDL | 2025-05-07 |
| 00190776392680 | Millennium | Avalign Technologies, Inc. | HDL | 2025-05-02 |
| 00194613065355 | MSI Precision Specialty Instruments | Med Saver, Inc. | HDL | 2025-03-21 |
| 00198506081163 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2025-03-12 |
| 00198506081170 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2025-03-12 |
| 00198506075360 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2025-02-18 |
| 00850071684254 | Realstar Surgical | REAL STAR SURGICAL INSTRUMENTS | HDL | 2025-01-21 |
| 00198506074462 | ELMED INCORPORATED | ELMED INCORPORATED | HDL | 2025-01-20 |
| 00198506074479 | ELMED INCORPORTED | ELMED INCORPORATED | HDL | 2025-01-20 |
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