Primary Device ID | B227NRP1303 |
NIH Device Record Key | 588b5e22-0586-41a3-84fc-45332a3b9511 |
Commercial Distribution Discontinuation | 2030-11-24 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter |
Version Model Number | R-420-159 |
Catalog Number | R-420-159 |
Company DUNS | 608625823 |
Company Name | NORTH EAST SCIENTIFIC INC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B227NRP1303 [Primary] |
QTF | Reprocessed Atherectomy 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 | 2023-09-25 |
Device Publish Date | 2023-09-15 |
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