Home GUDID 00841494104504 ROOT-CAL
Primary DI 00841494104504
Brand ROOT-CAL
Company Cynosure, LLC
Model ERC137
Catalog number ERC137
Device description ROOT-CAL,2.5ML SYRINGE 98% CAL HYDROXIDE
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EJK LINER, CAVITY, CALCIUM HYDROXIDE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EJK Liner, Cavity, Calcium Hydroxide Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841494104504 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841494104504 00841494104504 841494104504 0841494104504
GMDN Terms# Term, Definition table Term Definition Calcium hydroxide dental cement A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused.
Regulatory Flags# DUNS number 780318028 Device count 1 DM exempt true Premarket exempt true Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841494100025 Focus Cap Array 100-7012-055 2016-09-24 00841494100001 PicoSure 100-7012-010 2016-09-24 00841494100056 Elite MPX 100-7009-010 2016-09-24 00841494100063 Elite+ 100-7018-010 2016-09-24 00841494100070 Apogee+ 100-7018-290 2016-09-24 00841494100100 Accolade 100-7008-010 2016-09-24 00841494100551 Spacer tip, handpiece 130-7012-324 2016-09-24 00841494100568 Spacer tip for 532 Handpiece 130-7012-490 2016-09-24 00841494103354 532 Lite Handpiece 659-0644 2016-09-24 00841494103583 PicoSure 1064 nm Handpiece 100-7012-079 2016-09-24 00841494103590 PicoSure 532 nm Handpiece 100-7012-076 2016-09-24 00841494103675 Elite+ / Elite MPX Treatment Tip 100-7018-100 2016-09-24 00841494106775 SculpSure, Laser Assembly, Brazil 100-7026-020 2017-07-24 00841494106980 PicoSure 532 Delivery System 100-7012-532 2017-07-24 00841494106997 PicoSure 1064 Delivery System 100-7012-164 2017-07-24 00841494107246 Refusrbished, Handpiece, 1064, Pico R100-7012-079 2017-07-24 00841494107253 Refusrbished, Handpiece, 532, Pico R100-7012-076 2017-07-24 00841494104214 PERF-GRID EPG107 EPG107 2016-09-21 00841494104689 SPLINT GRID NYLON MESH ROLL ESG118 ESG118 2016-09-21 00841494104696 SPLINT MESH STAINLESS STEEL MESH ROLL ESG117 ESG117 2016-09-21
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