LOJIC+ 4222202

GUDID 09336472002091

LOJIC+ 2SP FAST 500

SDI LIMITED

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 09336472002091
• NIH Device Record Key: 715c422a-598c-4061-aa67-932e846d5107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOJIC+
• Version Model Number: 4222202
• Catalog Number: 4222202
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472002091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801639

FDA Product Code

• EJJ: Alloy, Amalgam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [LOJIC+]

• DO3642250002: LOJIC+ 5SP REG 500
• DO3642234042: LOJIC+ 3SP SLOW 500
• DO3642233032: LOJIC+ 3SP REG 500
• DO3642232022: LOJIC+ 3SP FAST 500
• DO3642224042: LOJIC+ 2SP SLOW 500
• DO3642223032: LOJIC+ 2SP REG 500
• DO3642222022: LOJIC+ 2SP FAST 500
• DO3642214042: LOJIC+ 1SP SLOW 500
• DO3642213032: LOJIC+ 1SP REG 500
• DO3642212022: LOJIC+ 1SP FAST 500
• DO3642050002: LOJIC+ 5SP REG 50
• DO3642034042: LOJIC+ 3SP SLOW 50
• DO3642033032: LOJIC+ 3SP REG 50
• DO3642032022: LOJIC+ 3SP FAST 50
• DO3642024042: LOJIC+ 2SP SLOW 50
• DO3642023032: LOJIC+ 2SP REG 50
• DO3642022022: LOJIC+ 2SP FAST 50
• DO3642014042: LOJIC+ 1SP SLOW 50
• DO3642013032: LOJIC+ 1SP REG 50
• DO3642012022: LOJIC+ 1SP FAST 50
• 09336472002275: LOJIC+ 5SP REG 500
• 09336472002213: LOJIC+ 3SP REG 500
• 09336472002183: LOJIC+ 3SP FAST 500
• 09336472002152: LOJIC+ 2SP SLOW 500
• 09336472002121: LOJIC+ 2SP REG 500
• 09336472001773: LOJIC+ 5SP REG 50
• 09336472001704: LOJIC+ 3SP REG 50
• 09336472001674: LOJIC+ 3SP FAST 50
• 09336472001643: LOJIC+ 2SP SLOW 50
• 09336472001599: LOJIC+ 2SP REG 50
• 09336472001551: LOJIC+ 2SP FAST 50
• 09336472001513: LOJIC+ 1SP SLOW 50
• 09336472001476: LOJIC+ 1SP REG 50
• 09336472001452: LOJIC+ 1SP FAST 50
• 09336472002091: LOJIC+ 2SP FAST 500