| Primary Device ID | 09348227002164 |
| NIH Device Record Key | b99c16d4-61fb-49f5-90ec-26caa49dc2a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VorOtek Speculums |
| Version Model Number | VPS-B50-L |
| Catalog Number | VPS-B50-L |
| Company DUNS | 744332997 |
| Company Name | VOROTEK PTY LTD |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09348227002164 [Primary] |
| EPY | Speculum, Ent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2023-09-08 |
| 09348227002201 | VorOtek Speculums - XSmall. Pack of 50 XSmall Speculums. Autoclavable plastic |
| 09348227002195 | VorOtek Speculums - XLarge. Pack of 50 XLarge Speculums. Autoclavable plastic |
| 09348227002188 | VorOtek Speculums - Small. Pack of 50 Small Speculums. Autoclavable plastic |
| 09348227002171 | VorOtek Speculums - Medium. Pack of 50 Medium Speculums. Autoclavable plastic |
| 09348227002164 | VorOtek Speculums - Large. Pack of 50 Large Speculums. Autoclavable plastic |