FDA UDI
In Commercial Distribution
🇺🇸 United States
EBA ONE
DI: 08059386741108
·
Model: Nails ruler kit with wire ø2,5x800mm
·
CITIEFFE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EBA ONE
- Primary DI
- 08059386741108
- Version / Model
- Nails ruler kit with wire ø2,5x800mm
- Catalog Number
- EBA-5233
- Company Name
- CITIEFFE SRL
- Labeler DUNS
- 431406875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-19
- Public Version
- 2
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- f59a0cca-348e-4617-9705-bd4cd41eeef1
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
- No
- 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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57833 | Medical ruler, single-use | A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08059386741108 | GS1 |
Customer Contacts
- Phone
- +39051721850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183666 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry and clean environment and avoid damaging the packing. Room temperature.