Primary Device ID | M595S2720 |
NIH Device Record Key | 5774bb88-53f8-4595-be8f-2824337032ef |
Commercial Distribution Discontinuation | 2019-01-01 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | SEcure® |
Version Model Number | S272 |
Catalog Number | S272 |
Company DUNS | 009900424 |
Company Name | PARKELL, 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 |
Phone | 6312491134 |
customerservice@parkell.com |
Special Storage Condition, Specify | Between 0 and 0 *Must be refrigerated when not in use. Avoid excessive heat, sunlight and moisture. |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M595S2720 [Primary] |
EMA | Cement, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-03-29 |
Device Publish Date | 2016-09-23 |
00810000529551 | SEcure® Dentin Shade Resin Cement 9g Syringe (with 10 Tips) |
00810000529544 | SEcure® White Opaque Shade Resin Cement 9g Syringe (with 10 Tips) |
00810000529537 | SEcure® Translucent Shade Resin Cement 9g Syringe (with 10 Tips) |
00810000529520 | SEcure® Self-Etch Primer 3ml |
00810000529513 | SEcure® Resin Cement System Kit with Translucent Shade |
M595S2740 | SEcure® Dentin Shade Resin Cement 9g Syringe (with 10 Tips) |
M595S2730 | SEcure® White Opaque Shade Resin Cement 9g Syringe (with 10 Tips) |
M595S2720 | SEcure® Translucent Shade Resin Cement 9g Syringe (with 10 Tips) |
M595S2710 | SEcure® Self-Etch Primer 3ml |
M595S2700 | SEcure® Resin Cement System Kit with Translucent Shade |
10810000526847 | Mixing Tip with Brown Base for SEcure® (Pkg. of 30 pcs.) |
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