| Primary Device ID | 09349967000267 |
| NIH Device Record Key | fcd412e6-c6fc-4d56-ba86-362ef8a4698f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ColpotomizOR Tube |
| Version Model Number | 35mm |
| Catalog Number | C35-TV |
| Company DUNS | 753476779 |
| Company Name | SURGI SUPPLIES INTERNATIONAL PTY. LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09349967000243 [Primary] |
| GS1 | 09349967000250 [Package] Contains: 09349967000243 Package: Outer box [5 Units] In Commercial Distribution |
| GS1 | 09349967000267 [Package] Contains: 09349967000250 Package: Shipper Carton [3 Units] In Commercial Distribution |
| HEW | Culdoscope (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-04-04 |
| Device Publish Date | 2016-09-22 |
| 09349967000298 | 45mm diameter trans-vaginal tube |
| 09349967000267 | 35mm diameter trans-vaginal tube |