FDA UDI
In Commercial Distribution
🇺🇸 United States
CEKA & PRECI-LINE ATTACHMENTS
DI: 04260576941039
·
Model: 1601
·
Alphadent NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEKA & PRECI-LINE ATTACHMENTS
- Primary DI
- 04260576941039
- Version / Model
- 1601
- Catalog Number
- 1601
- Company Name
- Alphadent NV
- Labeler DUNS
- 283174985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- 31f4f512-e117-4cc7-b703-fe18f0465255
Device Description
Perma-Ret set
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 |
|---|---|---|---|---|
| 38608 | Dental wrought alloy | A wrought alloy (metal) intended to be used in dentistry to make individually formed retentive elements, clasps for removable dentures, posts for orthodontic appliances, and other dental devices. It is marketed in a variety of forms, dimensions and materials. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260576941039 | GS1 |
Customer Contacts
- Phone
- +328004969500
- [email protected]