FDA UDI
In Commercial Distribution
🇺🇸 United States
Dalbo®-Classic
DI: 07640173090106
·
Model: 055701
·
Cendres+Métaux SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dalbo®-Classic
- Primary DI
- 07640173090106
- Version / Model
- 055701
- Catalog Number
- 055701
- Company Name
- Cendres+Métaux SA
- Labeler DUNS
- 487506230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-31
- Public Version
- 1
- Public Version Date
- 2020-04-08
- Public Version Status
- New
- Public Device Record Key
- 8319747c-7db5-42e2-bdb3-64b6a96a244f
Device Description
Dalbo®-Classic EK basic
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGG | Attachment, Precision, All | Dental | 872.3165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46307 | Dental anchor | A device made of austenitic alloys or alloys containing 75 percent or greater gold (Au) or metals of the platinum group, intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640173090106 | GS1 |
Customer Contacts
- Phone
- +41583602000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight