| Primary Device ID | E29953029 |
| NIH Device Record Key | bec1378b-7c39-4d78-a25a-1f4df9464af5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | endo-stop |
| Version Model Number | 5302 |
| Company DUNS | 481461598 |
| Company Name | Polydentia SA |
| Device Count | 100 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E29953020 [Primary] |
| HIBCC | E29953029 [Unit of Use] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E29953029]
Moist Heat or Steam Sterilization
[E29953029]
Moist Heat or Steam Sterilization
[E29953029]
Moist Heat or Steam Sterilization
[E29953029]
Moist Heat or Steam Sterilization
[E29953029]
Moist Heat or Steam Sterilization
[E29953029]
Moist Heat or Steam Sterilization
[E29953029]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-13 |
| Device Publish Date | 2022-07-05 |
| E29953100 | assorted |
| E29953089 | red-brown |
| E29953079 | black |
| E29953069 | green |
| E29953059 | blue |
| E29953049 | red |
| E29953039 | yellow |
| E29953029 | white |
| E29953019 | opaque |