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 |