FDA UDI
In Commercial Distribution
🇺🇸 United States
Susol® Emery Board 18cm
DI: 05060418833671
·
Model: CH145
·
BAILEY INSTRUMENTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Susol® Emery Board 18cm
- Primary DI
- 05060418833671
- Version / Model
- CH145
- Company Name
- BAILEY INSTRUMENTS LTD
- Labeler DUNS
- 769260357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-27
- Public Version
- 1
- Public Version Date
- 2024-03-06
- Public Version Status
- New
- Public Device Record Key
- 374782b1-1dca-4afb-a260-d079f79a79d4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64927 | Nail emery board | A hand-held manual device intended to grind down fingernails or toenails with an abrasive action typically to remove debris and/or smooth the nail. It is in the form of a double-sided wooden file with an emery paper covering. It is available for use by a patient/layperson outside a clinical environment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060418833671 | GS1 |