N/A
- Primary DI
- 20705036015809
- Brand
- N/A
- Company
- ETHICON ENDO-SURGERY, LLC
- Model
- BX33
- Catalog number
- BX33
- Device description
- Bariatric Laparoscopic Sleeve Gastrectomy kit
- Published
- 2017-06-06
- 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
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20705036015809 | Primary | GS1 | 0 | |
| 10705036015802 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 20705036015809 | 20705036015809 |
| 10705036015802 | 10705036015802 |
GMDN Terms
| Term | Definition |
|---|
| Laparoscopic surgical procedure kit, non-medicated, single-use | A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -22 Degrees Celsius | 60 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 044606982
- Device count
- 4
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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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