Amtouch Etchant Gel AMETCHJUMBO

GUDID 00850058951010

Amtouch Etchant Gel 37%, Medium Viscosity, Jumbo Refill, 25ml (2x Syringes)

AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.

Dental etching solution
Primary Device ID00850058951010
NIH Device Record Keya2406070-70a5-4e40-a257-bde99da71135
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmtouch Etchant Gel
Version Model NumberJumbo Refill 25ml
Catalog NumberAMETCHJUMBO
Company DUNS180611519
Company NameAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage

Device Identifiers

Device Issuing AgencyDevice ID
GS100850058951010 [Primary]

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-23
Device Publish Date2024-05-15

On-Brand Devices [Amtouch Etchant Gel]

00850058951010Amtouch Etchant Gel 37%, Medium Viscosity, Jumbo Refill, 25ml (2x Syringes)
00850058951003Amtouch Etchant Gel 37%, Medium Viscosity, Jumbo Kit, 25ml (1x Syringes, 2x Tips)
00850048528994Amtouch Etchant Gel 37%, Medium Viscosity, 1.2ml (24x Syringes)
00850048528987Amtouch Etchant Gel 37%, Medium Viscosity, 1.2ml (4x Syringes, 4x Tips)

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