Primary Device ID | 00303620000529 |
NIH Device Record Key | f979476d-f02b-4f7b-9466-666dd7bf15b0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SEPTODONT ADHERENCE SC 2-9GM DBL BAR SYR |
Version Model Number | 01C2003 |
Catalog Number | 01C2003 |
Company DUNS | 012925513 |
Company Name | SEPTODONT, 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 | true |
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 | (303) 665-7535 |
usregulatoryaffairs@septodont.com |
Weight | 9 Gram |
Storage Environment Temperature | Between 15 Degrees Celsius and 24 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00303620000529 [Primary] |
EBF | Material, Tooth Shade, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-12 |
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