n.a.
- Primary DI
- 04048551225752
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 11009BC1
- Device description
- Broncho-Fiberscope 5.6 x 54
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551225752 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551225752 | 04048551225752 | 4048551225752 |
GMDN Terms
| Term | Definition |
|---|---|
| Flexible fibreoptic bronchoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid |
Regulatory Flags
- DUNS number
- 315731430
- 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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| 04048438008911 | NA | 051110-10 | 051110-10 | 2025-03-28 |
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