Smit Sleeve 40mm

GUDID B1657002327022825053

Smit Sleeve 40mm

Liberty Medical , Inc.

Cervical/intrauterine brachytherapy system applicator, manual

• Primary Device ID: B1657002327022825053
• NIH Device Record Key: 0528d35a-4d32-4360-9946-1e48e416a124
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smit Sleeve 40mm
• Version Model Number: 7002
• 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	B1657002327022825053 [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.

• B16558100327022825157 - Small Prostate Brachytherapy Kit-metal hub: 2025-07-29 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy
• B16558110327033125158 - Medium Prostate Brachytherapy Kit-metal hub: 2025-07-29 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy
• B16558120326123125159 - Large Prostate Brachytherapy Kit-metal hub: 2025-07-29 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy
• B16556350327063025015 - Implant Needle: 2025-07-08 17ga 20cm Implant needle with stylet
• B16557050327063025096 - Flexi-Needle: 2025-07-08 Flexible brachytherapy needle, 15ga, 30cm, stainless steel obturator, 1 per pack
• B16557640327063025077 - Flexi-Needle: 2025-07-08 Flexible brachytherapy needle, 15ga, 25cm, w/ female luer, stainless steel obturator, 1 per pack
• B16558010327033125085 - Medium Prostate Brachytherapy Kit: 2025-07-08 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy
• B16558010327033125129 - Medium Prostate Brachytherapy Kit: 2025-07-08 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy