Centurion CVI3505
GUDID 00653160350067
VASCULAR ACCESS BUNDLE
CENTURION MEDICAL PRODUCTS CORPORATION
General surgical procedure kit, medicated| Primary Device ID | 00653160350067 |
| NIH Device Record Key | 4c5c82b2-a576-46bf-93e3-0501ddb8ee56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Centurion |
| Version Model Number | CVI3505 |
| Catalog Number | CVI3505 |
| 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 | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653160350067 [Package] Contains: 10653160350064 Package: CASE [5 Units] In Commercial Distribution |
| GS1 | 10653160350064 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212258
FDA Product Code
| LRO | General surgery tray |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-24 |
| Device Publish Date | 2022-01-14 |
On-Brand Devices [Centurion]
Trademark Results [Centurion]
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