Blox™
- Primary DI
- 00816849016764
- Brand
- Blox™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- SBT-321
- Catalog number
- SBT-321
- Device description
- Endoscopic Bite Block with Elastic Cloth Strap
- Published
- 2018-12-01
- 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
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| MNK | Endoscopic bite block |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| MNK | Endoscopic Bite Block | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816849016764 | Package | GS1 | 100 | In Commercial Distribution |
| 00840253108838 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816849016764 | 00816849016764 | 816849016764 | 0816849016764 |
| 00840253108838 | 00840253108838 | 840253108838 | 0840253108838 |
GMDN Terms
| Term | Definition |
|---|---|
| Endoscopic bite block, basic, single-use | A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 021717889
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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