AlgiMac

GUDID D105MI901311

AlgiMac Alginate Substitute, Fast Set Mint Flavor - 50mL Cartridge

Surgimac LLC

Silicone dental impression material
Primary Device IDD105MI901311
NIH Device Record Key9c9281a2-233f-4271-9884-feac97be1d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlgiMac
Version Model NumberMI-9013-1
Company DUNS060635048
Company NameSurgimac LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD105MI901311 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-26
Device Publish Date2025-06-18

On-Brand Devices [AlgiMac]

D105MI90130AlgiMac Alginate Substitute, Fast Set Mint Flavor, box of 4-50mL Cartridges
D105MI901311AlgiMac Alginate Substitute, Fast Set Mint Flavor - 50mL Cartridge
D105MI90120AlgiMac Alginate Substitute, Fast Set Mint Flavor, box of 8-50mL Cartridges
D105MI901211AlgiMac Alginate Substitute, Fast Set Mint Flavor -50mL Cartridge

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