Primary Device ID | D6581340012 |
NIH Device Record Key | 813877c7-791f-4ab7-9479-6d2a8dc8afd7 |
Commercial Distribution Discontinuation | 2020-03-06 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | COE-FLO™ |
Version Model Number | 134001 |
Catalog Number | 134001 |
Company DUNS | 005473608 |
Company Name | Gc America Inc. |
Device Count | 1 |
DM Exempt | false |
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 | false |
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(708)597-0900 |
customerservice@gcamerica.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D6581340011 [Primary] |
HIBCC | D6581340012 [Package] Contains: D6581340011 Package: Carton [12 Units] Discontinued: 2018-05-01 Not in Commercial Distribution |
ELW | MATERIAL, IMPRESSION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-03-06 |
Device Publish Date | 2016-08-01 |
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