| Primary Device ID | 00842092181768 |
| NIH Device Record Key | eecb9d04-457f-4f40-9616-57eb8f4d2d27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sphero Flex |
| Version Model Number | 0828613 |
| Catalog Number | 0828613 |
| Company DUNS | 117776048 |
| Company Name | Preat Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com | |
| Phone | +1 (800) 232-7732 |
| info@preat.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842092181768 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
[00842092181768]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-27 |
| Device Publish Date | 2023-09-19 |
| 00842092165195 | Sphero Flex Abutment Nobel Active/Conical NP x 1mm |
| 00842092181430 | Sphero Flex Abutment Branemark RP x 2mm |
| 00842092181423 | Sphero Flex Abutment Branemark RP x 1mm |
| 00842092181768 | Sphero Flex Abutment Calcitek Integral 3.25 x 2mm (2.5mm Ball) |
| 00842092181751 | Sphero Flex Abutment Calcitek Integral 3.25 x 4mm (2.5mm Ball) |