Cardiac Tube Holder
- Primary DI
- B354OSCVORTH0
- Brand
- Cardiac Tube Holder
- Company
- ORANGE SURGICAL INSTRUMENTS, LLC
- Model
- OS-CVOR-TH
- Catalog number
- OS-CVOR-TH
- Device description
- Cardiac Tube Holder
- Published
- 2016-11-15
- Public version status
- Update
- Distribution status
- Not 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 |
|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B354OSCVORTH0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Tissue extraction bag | An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device. |
Regulatory Flags
- DUNS number
- 047063695
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- 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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