NEW BEGINNINGS® GELSHAPES®

GUDID 10650551093661

GELSHAPES®, LARGE BREAST FORM, 6.5"X13"

PMT CORPORATION

Scar-management dressing, single-use

• Primary Device ID: 10650551093661
• NIH Device Record Key: ada12e64-5d90-4cc6-a853-dd59acaa21ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEW BEGINNINGS® GELSHAPES®
• Version Model Number: 3505-3
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10650551093661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930409

FDA Product Code

• MDA: Elastomer, Silicone, For Scar Management

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 [NEW BEGINNINGS® GELSHAPES®]

• 20650551093620: GELSHAPES®, RECTANGLE, 4"X5.5", QTY. 6
• 10650551093692: GELSHAPES®, ABDOMINAL, 3"X15"
• 10650551093685: GELSHAPES®, KEYHOLE, 8"X3" DISC DIAMETER
• 10650551093678: GELSHAPES®, BREAST DISC, 3" DIAMETER
• 10650551093661: GELSHAPES®, LARGE BREAST FORM, 6.5"X13"
• 10650551093654: GELSHAPES®, SMALL BREAST FORM, 5"X10.5"
• 10650551093647: GELSHAPES®, STRIP, 1.5"X11"
• 10650551093630: GELSHAPES®, RECTANGLE, 7.5"X12"
• 10650551093623: GELSHAPES®, RECTANGLE, 4"X5.5"