FDA UDI
In Commercial Distribution
🇺🇸 United States
Helix Conical Reamers
DI: 07350081492281
·
Model: RSI-345
·
Dentatus AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Helix Conical Reamers
- Primary DI
- 07350081492281
- Version / Model
- RSI-345
- Catalog Number
- RSI-345
- Company Name
- Dentatus AB
- Labeler DUNS
- 355803412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-20
- Public Version
- 1
- Public Version Date
- 2024-09-30
- Public Version Status
- New
- Public Device Record Key
- 9571d367-f3d7-47dc-8d78-0ec2585d1896
Device Description
3x Assorted Helix Conical Reamers for Luscent Anchors - Sizes 3 to 5 Extra Long (1 of each size)
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
- Yes
- 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 |
|---|---|---|---|---|
| DZA | Drill, Dental, Intraoral | Dental | 872.4130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43311 | Pin/post dental drill bit | A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350081492281 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.35 | Millimeter | |
| Outer Diameter | 1.50 | Millimeter | |
| Outer Diameter | 1.65 | Millimeter | |
| Length | 37 | Millimeter |