| Primary Device ID | E2995015PLUS9 |
| NIH Device Record Key | da662c0a-13a1-4c13-9ea1-482f5626ed91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | wood wedges |
| Version Model Number | 5015PLUS |
| Catalog Number | 5015PLUS |
| Company DUNS | 481461598 |
| Company Name | Polydentia SA |
| Device Count | 1000 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E2995015PLUS0 [Primary] |
| HIBCC | E2995015PLUS9 [Unit of Use] |
| 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 | 2023-08-31 |
| Device Publish Date | 2023-08-23 |
| E29950600 | assorted (XS, S, M, L) 600 pcs |
| E29950400 | assorted (XS, S, M, L) 400 pcs |
| E29950179 | 17 mm (XL), 100 pcs. |
| E29950159 | 15 mm (L), 100 pcs. |
| E29950139 | 13 mm (M), 100 pcs. |
| E29950129 | 12 mm (S), 100 pcs. |
| E29950010 | assorted (XS, S, M, L) 100 pcs. |
| E2995017PLUS9 | 17 mm (XL) 1000 pcs. |
| E2995015PLUS9 | 15 mm (L) 1000 pcs. |
| E2995013PLUS9 | 13 mm (M) 1000 pcs. |
| E2995012PLUS9 | 12 mm (S) 1000 pcs. |
| E2995001S9 | assorted 100 pcs. |
| E2995001PLUS9 | assorted (XS, S, M ,L) 1000 pcs. |
| E29950029 | 5002 |