| Primary Device ID | 05060967630271 |
| NIH Device Record Key | f3420e2f-b5a7-48c2-b3e4-d764dc08020a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Yomi One Implant System |
| Version Model Number | 54001 |
| Catalog Number | 54001 |
| Company DUNS | 509583543 |
| Company Name | Neoss 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 | true |
| OTC Over-The-Counter | false |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com | |
| Phone | 999-999-9999 |
| contact.usa@neoss.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060967630226 [Primary] |
| GS1 | 05060967630271 [Direct Marking] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
[05060967630271]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-23 |
| Device Publish Date | 2024-02-15 |
| 05060967630271 | Implant System Box |
| 05060967630196 | Dental Implant Ø5.0 x 17 mm |
| 05060967630189 | Dental Implant Ø5.0 x 15 mm |
| 05060967630172 | Dental Implant Ø5.0 x 13 mm |
| 05060967630165 | Dental Implant Ø5.0 x 11 mm |
| 05060967630158 | Dental Implant Ø5.0 x 9 mm |
| 05060967630141 | Dental Implant Ø4.5 x 17 mm |
| 05060967630134 | Dental Implant Ø4.5 x 15 mm |
| 05060967630127 | Dental Implant Ø4.5 x 13 mm |
| 05060967630110 | Dental Implant Ø4.5 x 11 mm |
| 05060967630103 | Dental Implant Ø4.5 x 9 mm |
| 05060967630097 | Dental Implant Ø4.0 x 17 mm |
| 05060967630080 | Dental Implant Ø4.0 x 15 mm |
| 05060967630073 | Dental Implant Ø4.0 x 13 mm |
| 05060967630066 | Dental Implant Ø4.0 x 11 mm |
| 05060967630059 | Dental Implant Ø4.0 x 9 mm |
| 05060967630042 | Dental Implant Ø3.5 x 17 mm |
| 05060967630035 | Dental Implant Ø3.5 x 15 mm |
| 05060967630028 | Dental Implant Ø3.5 x 13 mm |
| 05060967630011 | Dental Implant Ø3.5 x 11 mm |
| 05060967630004 | Dental Implant Ø3.5 x 9 mm |