| Primary Device ID | 05010058191426 |
| NIH Device Record Key | c3aae6ca-5457-4bc4-a0e2-28b591598979 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultraspec |
| Version Model Number | 9142 |
| Catalog Number | 9142 |
| Company DUNS | 237799775 |
| Company Name | ROBINSON HEALTHCARE LIMITED |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05010058091429 [Primary] |
| GS1 | 05010058191426 [Package] Contains: 05010058091429 Package: Box [30 Units] In Commercial Distribution |
| HIB | Speculum, Vaginal, Nonmetal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-29 |
| Device Publish Date | 2025-05-21 |
| 05010058191426 | EcoGold Speculum Extra-Small (Sterile Device) - E476 - Grey X30 |
| 05010058191570 | EcoGold Speculum Broad Sterile X25 |
| 05010058191532 | EcoGold Speculum Large Sterile X25 |
| 05010058191495 | EcoGold Speculum Medium-Long Sterile X25 |
| 05010058191471 | EcoGold Speculum Medium Sterile X25 |
| 05010058191457 | EcoGold Speculum Small Sterile X25 |