Primary Device ID | 10607915119901 |
NIH Device Record Key | 688905c1-b132-4b20-95df-4ac34fcecab6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Surseal® II |
Version Model Number | SEAL-005 |
Company DUNS | 187129135 |
Company Name | APPLIED MEDICAL RESOURCES CORPORATION |
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 |
Phone | 1.949.713.8300 |
contact@appliedmedical.com | |
Phone | 1.949.713.8300 |
contact@appliedmedical.com | |
Phone | 1.949.713.8300 |
contact@appliedmedical.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00607915119904 [Primary] |
GS1 | 10607915119901 [Package] Contains: 00607915119904 Package: [10 Units] In Commercial Distribution |
ODC | Endoscope Channel Accessory |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-08-22 |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURSEAL 87274884 not registered Live/Pending |
Georg Fischer Central Plastics LLC 2016-12-20 |