EndoRotor® Console ERC 20-01
GUDID 00865830000220
INTERSCOPE, INC
Tissue morcellation system control unit| Primary Device ID | 00865830000220 |
| NIH Device Record Key | d7a88cae-4deb-4beb-9b14-84180fd4c0fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoRotor® Console |
| Version Model Number | ERC 20-01 |
| Catalog Number | ERC 20-01 |
| Company DUNS | 968227913 |
| Company Name | INTERSCOPE, INC |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 1-800-461-4289 |
| info@interscopemed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865830000220 [Primary] |
FDA Product Code
| PTE | Endoscopic Morcellator Gastroenterology |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-12 |
| Device Publish Date | 2019-08-02 |
Devices Manufactured by INTERSCOPE, INC
Trademark Results [EndoRotor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOROTOR 86447058 5423689 Live/Registered |
Interscope, Inc. 2014-11-06 |
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