Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution
- Primary DI
- D0026751101
- Brand
- Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution
- Company
- DENTSPLY INTERNATIONAL INC.
- Model
- 675130
- Catalog number
- 675110
- Device description
- Hemoban® Gel Complete Package
- Published
- 2022-04-11
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MVL | CORD, RETRACTION |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MVL | Cord, Retraction | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D0026751101 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Gingival retraction solution | A liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Keep out of direct sunlight and store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. |
| Storage Environment Temperature | 18 Degrees Celsius | 29 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 083235549
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- 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
- true
- Sterilization required before use
- false
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