Prelude SNAP™ PLS-1010/A
GUDID 20884450468047
Merit Medical Systems, Inc.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 20884450468047 |
| NIH Device Record Key | b48ca6cc-c062-4952-bf17-45b258e3c7f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prelude SNAP™ |
| Version Model Number | 10884450468040 |
| Catalog Number | PLS-1010/A |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, Inc. |
| Device Count | 5 |
| DM Exempt | false |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450468043 [Unit of Use] |
| GS1 | 10884450468040 [Primary] |
| GS1 | 20884450468047 [Package] Contains: 10884450468040 Package: [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143255
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2020-09-01 |
| Device Publish Date | 2020-08-24 |
On-Brand Devices [Prelude SNAP™]
Trademark Results [Prelude SNAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRELUDE SNAP 97730633 not registered Live/Pending |
Merit Medical Systems, Inc. 2022-12-23 |
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