FDA UDI
In Commercial Distribution
🇺🇸 United States
Vortex
DI: 00810072351074
·
Model: Vortex
·
Cole Instruments Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vortex
- Primary DI
- 00810072351074
- Version / Model
- Vortex
- Catalog Number
- 920.000
- Company Name
- Cole Instruments Inc
- Labeler DUNS
- 078573265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-04
- Public Version
- 2
- Public Version Date
- 2023-07-21
- Public Version Status
- Update
- Public Device Record Key
- 15d357bc-ab17-4cb4-a86c-8acee0b129c0
Device Description
Vortex. Sterilize handpiece nosecone before first use and before each use.
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
- 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 |
|---|---|---|---|---|
| MOQ | Battery, Replacement, Rechargeable | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32033 | Battery box | A special container intended to be used to house batteries for protective purposes. This device will typically be portable so that the user can safely carry the power source. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810072351074 | GS1 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius