| Primary Device ID | 07350081492069 |
| NIH Device Record Key | 7a995904-224b-4685-9e81-d73334a517f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helix Classic Reamers |
| Version Model Number | RSB-6/3 |
| Catalog Number | RSB-6/3 |
| 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 | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Outer Diameter | 1.8 Millimeter |
| Length | 33 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350081492069 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
[07350081492069]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-09 |
| Device Publish Date | 2024-10-01 |
| 07350081491949 | 3x Helix Classic Reamers for #6 Posts - 1.80 Short |
| 07350081491932 | 3x Helix Classic Reamers for #5 Posts - 1.65 Short |
| 07350081491918 | 3x Helix Classic Reamers for #4 Posts - 1.50 Short |
| 07350081491895 | 3x Helix Classic Reamers for #3 Posts - 1.35 Short |
| 07350081492137 | 2x Helix Classic Reamers for #5 Posts - 1.65 Extra Long |
| 07350081492120 | 2x Helix Classic Reamers for #4 Posts - 1.50 Extra Long |
| 07350081492113 | 3x Assorted Helix Classic Reamers - Sizes #3 to #5 Extra Long (1 of each size) |
| 07350081492106 | 2x Helix Classic Reamers for #3 Posts - 1.35 Extra Long |
| 07350081492069 | 3x Helix Classic Reamers for #6 Posts - 1.80 Long |
| 07350081492052 | 3x Helix Classic Reamers for #5 Posts - 1.65 Long |
| 07350081492045 | 3x Assorted Helix Classic Reamers - Sizes #4 to #6 Long (1 of each size) |
| 07350081492038 | 3x Helix Classic Reamers for #4 Posts - 1.50 Long |
| 07350081492014 | 3x Helix Classic Reamers for #3 Posts - 1.35 Long |
| 07350081491925 | 3x Assorted Helix Classic Reamers - Sizes #4 to #6 Short (1 of each size) |