Primary Device ID | 04589551386765 |
NIH Device Record Key | ec24f2a0-88cd-46c4-bead-03b83be75ff1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FC-15 |
Version Model Number | FC-15 |
Company DUNS | 690710546 |
Company Name | NAKANISHI INC. |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04589551386765 [Primary] |
EKX | Handpiece, direct drive, ac-powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-13 |
Device Publish Date | 2023-06-05 |
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04560264502970 - EZ-M4 Adaptor | 2024-11-11 |
04589551392063 - EZ SPRAY | 2024-11-11 |
04589551391950 - M205 | 2024-10-24 |
04560264578586 - FX204 M4 | 2024-10-24 |
04589551389391 - Surgic Pro2 OPT | 2024-10-23 |