FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydro-Cast®
DI: D687730101
·
Model: 73010
·
Sultan Healthcare Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Hydro-Cast®
- Primary DI
- D687730101
- Version / Model
- 73010
- Company Name
- Sultan Healthcare Inc
- Labeler DUNS
- 056296981
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c68f38d5-485d-4d70-bed3-8d1be86a492a
Device Description
Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL Bottle Liquid, 1x130g Bottle Powder, 1x8mL Flow Replenisher
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17610 | Denture reliner, soft, professional | A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D6870073010FG2 | HIBCC | CASE | 12 | In Commercial Distribution | |
| Primary | D687730101 | HIBCC |
Customer Contacts
- Phone
- +1(800)989-8825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 8 | Milliliter | |
| Weight | 120 | Gram | |
| Total Volume | 115 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry.
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 27 Degrees Celsius