| Primary Device ID | E29974000 |
| NIH Device Record Key | bdc4eff4-bccd-4d1e-a033-406907fd7cc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | myWedge |
| Version Model Number | 7400 |
| Company DUNS | 481461598 |
| Company Name | Polydentia SA |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 | |
| 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 | |
| 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 | |
| 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 | E29974000 [Primary] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-14 |
| Device Publish Date | 2022-07-06 |
| E29974000 | assorted (XS, S, M, L) 400 pcs. |
| E29971049 | L yellow 50 pcs. |
| E29971039 | M green 50 pcs. |
| E29971029 | S orange 50 pcs. |
| E29971019 | XS pink 50 pcs. |
| E29971000 | assorted (XS, S, M, L) 100 pcs. |