FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultimate Ice
DI: D849405045
·
Model: 405045
·
Ultimate Dental
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ultimate Ice
- Primary DI
- D849405045
- Version / Model
- 405045
- Company Name
- Ultimate Dental
- Labeler DUNS
- 073515165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- cbddec1b-3fc8-48f5-b580-ae24d2ba55a6
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- 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 |
|---|---|---|---|---|
| ETA | Replacement, Ossicular Prosthesis, Total | Ear, Nose, Throat | 874.3495 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11068 | Ophthalmic cryosurgical system, mechanical | An assembly of mechanical devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes a mechanical regulator to control the flow of cryogen contained in an attached cylinder, and dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue. The device is typically used to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumours. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D849405045 | HIBCC |
Customer Contacts
- Phone
- 800-388-7868
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 120 Degrees Fahrenheit