FDA UDI
In Commercial Distribution
🇺🇸 United States
Reicodent
DI: 04061644035366
·
Model: 02-1702-10 C
·
devemed GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reicodent
- Primary DI
- 04061644035366
- Version / Model
- 02-1702-10 C
- Company Name
- devemed GmbH
- Labeler DUNS
- 506826739
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-07
- Public Version
- 1
- Public Version Date
- 2020-04-15
- Public Version Status
- New
- Public Device Record Key
- 65c8c0f5-d7b2-4134-b28c-96587b32b782
Device Description
Filling instrument, pear-shaped 0.8 / 1.0 mm COMFORT | SL | double ended
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIY | Instrument, Filling, Plastic, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16460 | Dental amalgam condenser, reusable | A hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04061644035366 | GS1 |
Customer Contacts
- Phone
- +4974679491990
- [email protected]