Primary Device ID | 09349967002629 |
NIH Device Record Key | 4908a4ba-3d8b-481b-8280-dc6c2facced6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ColpotomizOR Tube |
Version Model Number | C45-TV |
Company DUNS | 744346235 |
Company Name | THE O R COMPANY 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 | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09349967002605 [Primary] |
GS1 | 09349967002612 [Package] Contains: 09349967002605 Package: Outer [5 Units] In Commercial Distribution |
GS1 | 09349967002629 [Package] Contains: 09349967002612 Package: Shipper [3 Units] In Commercial Distribution |
HEW | Culdoscope (And Accessories) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-04 |
Device Publish Date | 2019-03-27 |
09349967002629 | C45-TV |
09349967002599 | C35-TV |
09349967001479 | 45mm diameter trans-vaginal tube, 3 way valve, Silicone tie |
09349967001448 | 35mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie |