Primary Device ID | M52550631 |
NIH Device Record Key | d63a8829-b5ef-4e5e-ac1e-10138b6940d4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ColoScreen iFOBT Mailer |
Version Model Number | 5063 |
Company DUNS | 079396131 |
Company Name | HELENA LABORATORIES CORPORATION |
Device Count | 30 |
DM Exempt | false |
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 | 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 |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M5250034640 [Unit of Use] |
HIBCC | M52550631 [Primary] |
KHE | REAGENT, OCCULT BLOOD |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-11-28 |
Device Publish Date | 2018-03-16 |
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