FDA UDI
In Commercial Distribution
🇺🇸 United States
Ritter Dental Implant System
DI: FRTSRP6011
·
Model: FR-TS-RP6011
·
Ritter Implants GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ritter Dental Implant System
- Primary DI
- FRTSRP6011
- Version / Model
- FR-TS-RP6011
- Company Name
- Ritter Implants GmbH & Co. KG
- Labeler DUNS
- 342602800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-14
- Public Version
- 1
- Public Version Date
- 2025-03-24
- Public Version Status
- New
- Public Device Record Key
- 2132a933-9d91-42f1-877d-3435632b706a
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55916 | Red cell plasmalogen IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of red blood cell plasmalogen in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | FRTSRP6011 | HIBCC |