Maryland Disector 33cm Disposable
- Primary DI
- B354OS335MD0
- Brand
- Maryland Disector 33cm Disposable
- Company
- ORANGE SURGICAL INSTRUMENTS, LLC
- Model
- OS-33-5-MD
- Catalog number
- OS-33-5-MD
- Device description
- Maryland Disector 33cm Disposable
- Published
- 2016-11-07
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
|---|
| B354OS335MD10 | Package | HIBCC | 10 | Not in Commercial Distribution |
| B354OS335MD0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Endoscopic electrosurgical electrode, monopolar, single-use | A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. 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
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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