FDA UDI
In Commercial Distribution
🇺🇸 United States
FRIOS®
DI: 07392532233364
·
Model: 59-8003
·
Dentsply Implants Manufacturing GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FRIOS®
- Primary DI
- 07392532233364
- Version / Model
- 59-8003
- Catalog Number
- 59-8003
- Company Name
- Dentsply Implants Manufacturing GmbH
- Labeler DUNS
- 344038836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-15
- Public Version
- 1
- Public Version Date
- 2022-07-25
- Public Version Status
- New
- Public Device Record Key
- 83292a5e-1f34-4f71-ae3d-0e465fe82733
Device Description
Drill Set for FRIOS® SinusSet
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, implant, dental, endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45147 | Dental/maxillofacial surgical procedure kit, non-medicated, reusable | A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07392532233364 | GS1 |