FDA UDI
In Commercial Distribution
🇺🇸 United States
DENALI
DI: 00810042120389
·
Model: 0251-L
·
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENALI
- Primary DI
- 00810042120389
- Version / Model
- 0251-L
- Company Name
- ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
- Labeler DUNS
- 077801124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-21
- Public Version
- 1
- Public Version Date
- 2020-04-29
- Public Version Status
- New
- Public Device Record Key
- a03a0fac-20d7-404c-82bb-a623da71622c
Device Description
NITI Ice Instrument
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMN | Scaler, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44860 | Orthodontic appliance archwire-cooling device | A hand-held dental instrument used in orthodontics to intraorally chill or cool thermally-activated archwires when placing bends in an orthodontic appliance. The device, after it has been precooled (typically with a cryogenic spray), is applied to a desired point of contact on the wire to extract heat and allow easy bending. As the archwire warms to body temperature it attempts to return to its former shape, and thus contributes to the application of forces within the mouth. The device is typically formed as a heavy-duty stainless steel rod with an insulated plastic handle and a slot at the distal end to accept wire. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810042120389 | GS1 |