FDA UDI
In Commercial Distribution
🇺🇸 United States
Ring Cup - 2 Pocket
DI: 00810072351166
·
Model: Ring Cup - 2 Pocket
·
Cole Instruments Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Ring Cup - 2 Pocket
- Primary DI
- 00810072351166
- Version / Model
- Ring Cup - 2 Pocket
- Catalog Number
- 360.200
- Company Name
- Cole Instruments Inc
- Labeler DUNS
- 078573265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- e225d88c-8976-4d8a-baf1-044a0e516ccd
Device Description
Holds follicles on a ring cup before they are inserted into the recipient area of a patient's forehead during hair restoration.
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHR | Pad, Denture, Over The Counter | Dental | 872.3540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45726 | Medicine cup, reusable | A cup specially designed for administering medicine to patients or disabled persons. It will typically be made of stainless steel or durable plastic materials and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810072351166 | GS1 |