Identity
- Trade Name
- NEW BEGINNINGS® GELSHAPES® FDA UDI
- Generic Name
- Scar-management dressing, single-use FDA UDI
- Device Name
- GELSHAPES®, BREAST DISC, 3" DIAMETER FDA UDI
- Model / Reference
- 3505-4 FDA UDI
- Description
- GELSHAPES®, BREAST DISC, 3" DIAMETER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10650551093678 FDA UDI
- 510(k) Number
- K930409 FDA UDI
- FDA Product Code
- MDA FDA UDI
- GMDN Term
- Scar-management dressing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, single-use
New Beginnings® Gelshapes® by Pmt Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scar-management dressing, single-use.
- ScarAway Silicone Acne Scar Gel — ALLIANCE PHARMA INC. · Class I
- H&H — TRONJEN MEDICAL TECHNOLOGY INC. · Class I
- Kelo-cote Advanced Formula Scar Gel — ALLIANCE PHARMA INC. · Class I
- NewGel+UV Silicone Gel for Scars + SPF30 — Newmedical Technology, Inc. · Class I
- ScarMD — AIM MEDICAL INC · Class I
- ScarAway Silicone Scar Gel — ALLIANCE PHARMA INC. · Class I
- Lorski — Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office · Class I
- Mepiform® — Mölnlycke Health Care AB · Class I
Cleared under the same submission
K930409 also covers:
- NEW BEGINNINGS® GEL SHEETING — Pmt Corp.
- NEW BEGINNINGS® GEL SHEETING — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pmt Corp.
Sources (1)
- FDA UDI 8e80860b-6ecf-4e0f-9820-435259d3ee9e 34 fields · synced May 30, 2026