FDA UDI
In Commercial Distribution
🇺🇸 United States
CEKA & PRECI-LINE ATTACHMENTS
DI: 14260576941449
·
Model: 2002G
·
Alphadent NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- CEKA & PRECI-LINE ATTACHMENTS
- Primary DI
- 14260576941449
- Version / Model
- 2002G
- Catalog Number
- 2002G
- 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
- 2
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- 527a58ae-2727-4ca5-8bcd-bb90db01f1a2
Device Description
PRECI-POST DENTIST YELLOW 50 PCS
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 |
|---|---|---|---|---|
| EGG | ATTACHMENT, PRECISION, ALL | Dental | 872.3165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45650 | Root canal post kit | A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04260576941442 | GS1 | ||||
| Primary | 14260576941449 | GS1 |
Customer Contacts
- Phone
- +328004969500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | plastic impression post,diameter tip yellow | ||
| Outer Diameter | 0.8 | Millimeter |