Smit Sleeve 20mm

GUDID B1657001327022825052

Smit Sleeve 20mm

Liberty Medical , Inc.

Cervical/intrauterine brachytherapy system applicator, manual

• Primary Device ID: B1657001327022825052
• NIH Device Record Key: 24bdb863-7435-46eb-81ee-1f6509495ece
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smit Sleeve 20mm
• Version Model Number: 7001
• Company DUNS: 967592978
• Company Name: Liberty Medical , Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1657001327022825052 [Primary]

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-10
• Device Publish Date: 2025-04-02

Devices Manufactured by Liberty Medical , Inc.

• B16556330628022825032 - Flexi-Needle: 2026-03-05 Flexible brachytherapy needle, 15ga, 23.5cm, stainless steel obturator, 5 per pack
• B16556510328022825225 - Medium Prostate Template: 2026-03-05 medium prostate template
• B16556620328013125172 - Intrauterine Tandem: 2026-03-05 Intrauterine tandem, 6mm OD, graduated
• B16558110327103126019 - Medium Prostate Brachytherapy Kit-metal hub: 2026-03-05 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy
• B16558110327123126026 - Medium Prostate Brachytherapy Kit-metal hub: 2026-03-05 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy
• B16559130328022824072 - Flexi-Needle: 2026-03-05 Flexible brachytherapy needle, 15ga, 30cm, w/ female luer, stainless steel obturator, 1 per pack
• B16570160328013125207 - Flexi-Needle: 2026-03-05 Flexible brachytherapy needle, 15ga, 25cm, stainless steel obturator, 1 per pack
• B16570160328022825246 - Flexi-Needle: 2026-03-05 Flexible brachytherapy needle, 15ga, 25cm, stainless steel obturator, 1 per pack