| Primary Device ID | 07350081492175 |
| NIH Device Record Key | 2aab2963-959d-4c63-86d7-72c3831a7b2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helix Conical Reamers |
| Version Model Number | RSG-4/3 |
| Catalog Number | RSG-4/3 |
| Company DUNS | 355803412 |
| Company Name | Dentatus AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Length | 28 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350081492175 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
[07350081492175]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-27 |
| Device Publish Date | 2024-09-19 |
| 07350081492304 | 2x Helix Conical Reamers for #5 Luscent Anchors - 1.65 Extra Long |
| 07350081492298 | 2x Helix Conical Reamers for #4 Luscent Anchors - 1.50 Extra Long |
| 07350081492274 | 2x Helix Conical Reamers for #3 Luscent Anchors - 1.35 Extra Long |
| 07350081492267 | 3x Helix Conical Reamers for #6 Luscent Anchors - 1.80 Long |
| 07350081492250 | 3x Helix Conical Reamers for #5 Luscent Anchors - 1.65 Long |
| 07350081492236 | 3x Helix Conical Reamers for #4 Luscent Anchors - 1.50 Long |
| 07350081492212 | 3x Helix Conical Reamers for #3 Luscent Anchors - 1.35 Long |
| 07350081492205 | 3x Helix Conical Reamers for #6 Luscent Anchors - 1.80 Short |
| 07350081492199 | 3x Helix Conical Reamers for #5 Luscent Anchors - 1.65 Short |
| 07350081492175 | 3x Helix Conical Reamers for #4 Luscent Anchors - 1.50 Short |
| 07350081492144 | 3x Helix Conical Reamers for #3 Luscent Anchors - 1.35 Short |
| 07350081492281 | 3x Assorted Helix Conical Reamers for Luscent Anchors - Sizes 3 to 5 Extra Long (1 of each size) |
| 07350081492243 | 3x Assorted Helix Conical Reamers for Luscent Anchors - Sizes 4 to 6 Long (1 of each size) |
| 07350081492182 | 3x Assorted Helix Conical Reamers for Luscent Anchors - Sizes 4 to 6 Short (1 of each size) |