Novo Surgical
- Primary DI
- G586OB6336340
- Brand
- Novo Surgical
- Company
- NOVO SURGICAL, INC.
- Model
- OB6336-34
- Catalog number
- OB6336-34
- Device description
- kristeller vaginal retractor, 8 3/4" (22.0 cm), size 3, 115.0 mm x 32.0 mm
- Published
- 2023-12-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- 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 |
|---|
| G586OB6336340 | 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
- 033029433
- 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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