ALLURA

GUDID 00650551000938

3321-16-N

PMT CORPORATION

Skin-port tissue expander

• Primary Device ID: 00650551000938
• NIH Device Record Key: bfc583f2-e1fe-4b15-85bd-7254fdd68385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLURA
• Version Model Number: 3321-16-N
• 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: 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
GS1	00650551000938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K845036

FDA Product Code

• LCJ: Expander, Skin, Inflatable

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: 2021-07-06
• Device Publish Date: 2021-06-28

On-Brand Devices [ALLURA]

• 00650551001775: CUSTOM VAGINAL STENT, CYLINDRICAL, 2X4CM, 12CC FILL
• 00650551000938: 3321-16-N
• 00650551000914: VAGINAL STENT, CYLINDRICAL, 4 SUTURE TABS, 4X12CM, 145CC FILL
• 00650551000808: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 4X11CM, 132CC FILL
• 00650551000792: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 3.5X10CM, 91CC FILL
• 00650551000785: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 3X9.5CM, 64CC FILL
• 00650551000778: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 1.5X8CM, 12CC FILL
• 00650551000761: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 4X16.5CM, 200CC FILL
• 00650551000754: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 4X15CM, 182CC FILL
• 00650551000747: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 4X14CM, 170CC FILL
• 00650551000730: VAGINAL STENT, CYLINDRICAL, SUTURE TABS, 4X12CM, 145CC FILL
• 00650551000723: VAGINAL STENT, CYLINDRICAL, 1.5X8CM, 12CC FILL
• 00650551000716: VAGINAL STENT, CYLINDRICAL, 3X9.5CM, 64CC FILL
• 00650551000709: VAGINAL STENT, CYLINDRICAL, 3.5X10CM, 91CC FILL
• 00650551000693: VAGINAL STENT, CYLINDRICAL, 4X11CM, 132CC FILL
• 00650551000686: VAGINAL STENT, CYLINDRICAL, 4X12CM, 145CC FILL
• 00650551000662: VAGINAL STENT, CYLINDRICAL, 4X15CM, 182CC FILL
• 00650551000655: VAGINAL STENT, CYLINDRICAL, 4X16.5CM, 200CC FILL
• 00065055100921: VAGINAL STENT, CYLINDRICAL, 4 SUTURE TABS, 4X14CM, 170CC FILL
• 00065055100679: VAGINAL STENT, CYLINDRICAL, 4X14CM, 170CC FILL
• 00650551002666: VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X12CM, 4CM PROJECTION, 115CC FILL
• 00650551002284: ALLURA STENT STYLET - 14CM
• 00650551002277: ALLURA STENT STYLET - 13CM
• 00650551002260: ALLURA STENT STYLET - 12CM
• 00650551002253: ALLURA STENT STYLET - 10CM
• 00650551002246: ALLURA STENT STYLET - 9CM
• 00650551002239: ALLURA STENT STYLET - 8CM
• 00650551002222: ALLURA STENT STYLET - 7CM
• 00650551002758: VAGINAL STENT, TAPERED CYLINDRICAL, 4 SUTURE TABS "X" LOCATION, 4X12CM, 4CM PROJECTION, 115CC FI