LOJIC + 4203404

GUDID 09336472001742

LOJIC+ 3SP SLOW 50

SDI LIMITED

Dental amalgam alloy
Primary Device ID09336472001742
NIH Device Record Key51cbc525-9072-45ed-b7e4-bc06c0d9dae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOJIC +
Version Model Number4203404
Catalog Number4203404
Company DUNS753221852
Company NameSDI LIMITED
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F)

Device Identifiers

Device Issuing AgencyDevice ID
GS109336472001742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJJAlloy, amalgam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-17
Device Publish Date2025-01-09

Devices Manufactured by SDI LIMITED

09336472002091 - LOJIC+2025-01-23 LOJIC+ 2SP FAST 500
09336472018580 - Set PP2025-01-23 SET PP INTRA-ORAL TIPS (10)
09336472001452 - LOJIC+2025-01-17 LOJIC+ 1SP FAST 50
09336472001476 - LOJIC+2025-01-17 LOJIC+ 1SP REG 50
09336472001513 - LOJIC+2025-01-17 LOJIC+ 1SP SLOW 50
09336472001551 - LOJIC+2025-01-17 LOJIC+ 2SP FAST 50
09336472001599 - LOJIC+2025-01-17 LOJIC+ 2SP REG 50
09336472001643 - LOJIC+2025-01-17 LOJIC+ 2SP SLOW 50

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