Novo Surgical Inc.
- Primary DI
- 00842331157066
- Brand
- Novo Surgical Inc.
- Company
- NOVO SURGICAL, INC.
- Model
- OB6338-64
- Catalog number
- OB6338-64
- Device description
- heaney hysterectomy retractor, blade 1 1/8" x 3 1/4" deep (2.9 cm x 8.3 cm), 6 3/4" (17.0 cm)
- Published
- 2022-11-12
- 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
- true
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 |
|---|
| 00842331157066 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00842331157066 | 00842331157066 | 842331157066 | 0842331157066 |
GMDN Terms
| Term | Definition |
|---|
| Vaginal rectocele reduction instrument | A non-sterile, hand-held, retractor-like device intended to be used to manually reduce a rectocele (herniation of lower bowel/rectum through a vaginal wall tear) during defecation to facilitate bowel emptying. It is intended to be used by direct application into the vagina by the patient during routine self-treatment to replace digital reduction and as an alternative to the more permanent pessary or surgical repair. It is typically made of plastic material and can be reused after appropriate cleaning. |
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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novosurgical.com