FDA UDI
In Commercial Distribution
🇺🇸 United States
CEKA & PRECI-LINE ATTACHMENTS
DI: 14260576941111
·
Model: 1704B
·
Alphadent NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- CEKA & PRECI-LINE ATTACHMENTS
- Primary DI
- 14260576941111
- Version / Model
- 1704B
- Catalog Number
- 1704B
- Company Name
- Alphadent NV
- Labeler DUNS
- 283174985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-03-30
- Public Version
- 1
- Public Version Date
- 2021-04-07
- Public Version Status
- New
- Public Device Record Key
- f0d6487c-7328-4504-b2f9-25c21be764d1
Device Description
Preci-Horix Plastic pattern 50pcs
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
- MR Safe
- Direct Marking Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJB | HANDLE, INSTRUMENT, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38580 | Sliding dental precision attachment | A device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04260576941114 | GS1 | ||||
| Primary | 14260576941111 | GS1 |
Customer Contacts
- Phone
- +328004969500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 4 | Millimeter | |
| Device Size Text, specify | bar |