Novo Surgical
- Primary DI
- G586G6911071
- Brand
- Novo Surgical
- Company
- NOVO SURGICAL, INC.
- Model
- G6911-07
- Catalog number
- G6911-07
- Device description
- universal ring retractor straight segment, for spinal retractor ring, 1 pair, small, 4" (10.0 cm)
- 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 Code Classifications
| Code | Device | Specialty | Class |
|---|
| GAD | Retractor | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G586G6911071 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Surgical retraction system mounting frame, reusable | A noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). 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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