Cystosure
GUDID 00866403000265
Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long
EMMY MEDICAL LLC
Rigid cystoscope| Primary Device ID | 00866403000265 |
| NIH Device Record Key | 0e509e9f-4c43-44e7-b2ac-6aea152e2109 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cystosure |
| Version Model Number | 10-330 |
| Company DUNS | 052321836 |
| Company Name | EMMY MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com | |
| Phone | 7758007300 |
| ron@cystosure.com |
Device Dimensions
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
| Outer Diameter | 2.7 Millimeter |
| Shaft Length | 270 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866403000265 [Primary] |
FDA Product Code
| FAJ | Cystoscope And Accessories, Flexible/Rigid |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00866403000265]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-25 |
| Device Publish Date | 2019-04-17 |
On-Brand Devices [Cystosure]
| 00866403000265 | Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long |
| 00866403000234 | Scope, 70 deg, 2.7 mm, long (270mm) |
| 00866403000210 | 16Fr Cystosure Plus, 16Fr, silicone catheter |
| 00866403000203 | Cystosure XL, 16 Fr, silicone catheter |
Trademark Results [Cystosure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYSTOSURE 86147836 4701068 Live/Registered |
Emmy Medical, LLC 2013-12-19 |
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