ALLURA®

GUDID 00650551005148

VAGINAL STENT, CYLINDRICAL, 2x5.5CM, 16CC FILL

PMT CORPORATION

Polymeric vaginal stent, non-bioabsorbable

• Primary Device ID: 00650551005148
• NIH Device Record Key: 39c3fdfe-e0e3-45ad-b04d-d9503b05c13a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLURA®
• Version Model Number: 3321-05
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551005148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202542

FDA Product Code

• KXP: Stent, Vaginal

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: 2025-03-27
• Device Publish Date: 2025-03-19

On-Brand Devices [ALLURA®]

• 00650551147619: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 4X16.5CM, 200CC FILL
• 00650551005148: VAGINAL STENT, CYLINDRICAL, 2x5.5CM, 16CC FILL
• 00650551003458: VAGINAL STENT, TAPERED CYLINDRICAL, 4 SUTURE TABS "N" PATTERN, 4X14CM, 4CM PROJECTION, 140CC FIL
• 00650551003236: VAGINAL STENT, CYLINDRICAL, 4X13CM, PROJECTION 4CM, FILL 157CC, 2 SUTURE TABS
• 00650551003229: VAGINAL STENT, CYLINDRICAL, 4X13CM, PROJECTION 4CM, FILL 157CC
• 00650551002932: VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X14CM, 4CM PROJECTION, 140CC FILL