Primary Device ID | 10884450532307 |
NIH Device Record Key | ebb0d8e3-22e7-4868-a338-a6b165e1c11c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prelude Roadster™ |
Version Model Number | 00884450532300 |
Catalog Number | PG6F90SX |
Company DUNS | 184763290 |
Company Name | Merit Medical Systems, 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 | 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 Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00884450532300 [Primary] |
GS1 | 10884450532307 [Package] Contains: 00884450532300 Package: [5 Units] In Commercial Distribution |
DYB | Introducer, catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-08-01 |
Device Publish Date | 2022-07-22 |
10884450531966 | 00884450531969 |
10884450532307 | 00884450532300 |
10884450532147 | 00884450532140 |
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10884450532345 | 00884450532348 |