FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution
DI: D0026751101
·
Model: 675130
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hemoban® Gel 25% Aluminum Chloride Hemostatic Solution
- Primary DI
- D0026751101
- Version / Model
- 675130
- Catalog Number
- 675110
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-11
- Public Version
- 1
- Public Version Date
- 2022-04-19
- Public Version Status
- New
- Public Device Record Key
- 4220b99e-7003-4d83-bb8c-300508573625
Device Description
Hemoban® Gel Complete Package
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVL | CORD, RETRACTION | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46423 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0026751101 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 29 Degrees Celsius