Surgical Direct
- Primary DI
- B382SD9176201040
- Brand
- Surgical Direct
- Company
- Surgical Direct, Inc.
- Model
- SD917620104
- Catalog number
- SD917620104
- Device description
- 3 Inch x 1 3/8 Inch Hill-Ferguson Rectal Retractor
- Published
- 2023-02-16
- 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 |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B382SD9176201040 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Rectal speculum | A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. 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
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|---|
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| 06438394010956 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
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| 00888867529793 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867529823 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00198506089510 | ELMED INCORPORATED | ELMED INCORPORATED | MDM | 2026-03-13 |
| 00810158219236 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
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| 00810158219250 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
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| 00810158219359 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
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| 00810158219007 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219014 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219021 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219038 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219069 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219090 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
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