| Primary Device ID | 04250676741769 | 
| NIH Device Record Key | 428b6199-58ad-4f76-a1e4-db97702880c3 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Dunn Dautrey osteotome | 
| Version Model Number | 20-445-04 | 
| Catalog Number | 20-445-04 | 
| Company DUNS | 332893028 | 
| Company Name | Spiggle & Theis Medizintechnik GmbH | 
| 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 | 
| c.winterschladen@spiggle-theis.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04250676741769 [Primary] | 
| GFI | OSTEOTOME, MANUAL | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
[04250676741769]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-10-06 | 
| Device Publish Date | 2025-09-26 | 
| 04250676741783 | strongly curved 8 mm, 17 cm | 
| 04250676741776 | strongly curved 6 mm, 17 cm | 
| 04250676741769 | strongly curved 4 mm, 17 cm | 
| 04250676741752 | slightly curved 8 mm, 17 cm | 
| 04250676741745 | slightly curved 6 mm, 17 cm | 
| 04250676741738 | slightly curved 4 mm, 17 cm | 
| 04250676741721 | straight 8 mm, 17 cm | 
| 04250676741714 | straight 6 mm, 17 cm | 
| 04250676741707 | straight 4 mm, 17 cm |