| Primary Device ID | 18050038832417 |
| NIH Device Record Key | 646f32b6-c252-464c-ba9d-e9d6dd412edb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RealGUIDE Sleeve |
| Version Model Number | 3DM00609ALPBP.10 |
| Company DUNS | 857172105 |
| Company Name | 3DIEMME SRL |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18050038832417 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-02 |
| Device Publish Date | 2024-04-24 |
| 18050038832691 | 3DM00608CUT.10 |
| 18050038830833 | 3DM00609MIS.10 |
| 18050038830734 | 3DM00605STR.10 |
| 18050038830703 | 3DM00605NEOSS.10 |
| 18050038830642 | 3DM00605NBL.WP.10 |
| 18050038830635 | 3DM00605NBL.RP.10 |
| 18050038830628 | 3DM00605NBL.NP.10 |
| 18050038830611 | 3DM00605MISNRW.10 |
| 18050038830604 | 3DM00605MIS.10 |
| 18050038830598 | 3DM00605MGNWD.10 |
| 18050038830581 | 3DM00605MGN.10 |
| 18050038830529 | 3DM00605ICXR.10 |
| 18050038830512 | 3DM00605ICXN.10 |
| 18050038830505 | 3DM00605GHISML.10 |
| 18050038830499 | 3DM00605GHILRG.10 |
| 18050038830413 | 3DM00605CAM43.10 |
| 18050038830406 | 3DM00605CAM38.10 |
| 18050038830284 | 3DM00605AST.EV.WD.10 |
| 18050038830277 | 3DM00605AST.EV.ND.10 |
| 18050038830215 | 3DM00605CAM33.10 |
| 18050038830185 | 3DM00604CAD6.10 |
| 18050038830178 | 3DM00604CAD5.10 |
| 18050038830161 | 3DM00604CAD4.10 |
| 18050038830154 | 3DM00604CAD3.10 |
| 18050038830147 | 3DM00604CAD2.10 |
| 18050038830130 | 3DM00604CAD11.10 |
| 18050038830123 | 3DM00604CAD10.10 |
| 18050038830093 | 3DM00604CAD0.10 |
| 18050038830390 | 3DM00605CAM33.10 |
| 18050038833155 | 3DM00605AZ48.10 |
| 18050038833148 | 3DM00605AZ33.10 |
| 18050038833131 | 3DM00605TUBM.10 |
| 18050038833124 | 3DM00605SMLPLT.10 |
| 18050038833087 | 3DM00605RES55-AT.10 |
| 18050038833070 | 3DM00605RES415-AT.10 |
| 18050038833032 | 3DM00605PILOT1.9.10 |
| 18050038833025 | 3DM00605ZIMB.10 |
| 18050038833018 | 3DM00605ZIMA.10 |
| 18050038832417 | 3DM00609ALPBP.10 |
| 18050038832400 | 3DM00605ALPBS.10 |
| 18050038832394 | 3DM00605ALPBL.10 |
| 18050038830222 | 3DM006053iSMALL.10 |
| 18050038830208 | 3DM00604CAD9.10 |
| 18050038830192 | 3DM00604CAD8.10 |
| 18050038833117 | 3DM00605CAM43.10 |
| 18050038833100 | 3DM00605CAM38.10 |
| 18050038833094 | 3DM00605CAM33.10 |