Centurion
GUDID 10653160177166
CENTURION MEDICAL PRODUCTS CORPORATION
Manual rectal irrigation system| Primary Device ID | 10653160177166 |
| NIH Device Record Key | 41720693-63cd-4a74-9b54-5f4555950b87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Centurion |
| Version Model Number | RI1000 |
| Company DUNS | 017246562 |
| Company Name | CENTURION MEDICAL PRODUCTS CORPORATION |
| 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 | true |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653160177169 [Primary] |
| GS1 | 10653160177166 [Package] Contains: 00653160177169 Package: CASE [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K960787
FDA Product Code
| LJH | System, irrigation, urological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-14 |
On-Brand Devices [Centurion]
Trademark Results [Centurion]
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