Primary Device ID | 00821925033108 |
NIH Device Record Key | f6133736-ede6-47d8-be10-5c51ef343ab7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Uro-EZDilate 15Fr (5mm) x 10cm |
Version Model Number | BURS0510 |
Company DUNS | 007198742 |
Company Name | Gyrus Acmi, 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 | 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 |
---|---|
GS1 | 00821925033108 [Primary] |
KOE | DILATOR, URETHRAL |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-05 |
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