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MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer FDA UDI
- Generic Name
- Invasive breast implant sizer, fixed, single-use FDA UDI
- Device Name
- Round Moderate Profile Saline Breast Implant Sizer, 225cc FDA UDI
- Model / Reference
- 351-225SZ FDA UDI
- Description
- Round Moderate Profile Saline Breast Implant Sizer, 225cc FDA UDI
Identifiers
- Catalog Number
- 351-225SZ FDA UDI
- Primary DI / UDI-DI
- 00081317002628 FDA UDI
- 510(k) Number
- K010709 FDA UDI
- FDA Product Code
- MRD FDA UDI
- GMDN Term
- Invasive breast implant sizer, fixed, single-use FDA UDI
Classification
- Device Class
- U 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
Yes
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
No
FDA UDI
Category: Invasive breast implant sizer, fixed, single-use
MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Invasive breast implant sizer, fixed, single-use.
- OPUS Silicone Gel Breast Implant Sizer — Sientra, Inc. · U
- Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 LP — SPECIALTY SURGICAL PRODUCTS, INC. · U
- NATRELLE INSPIRA Single Use Sizers — Allergan · U
- Round Breast Implant Sizer, High Projection — SPECIALTY SURGICAL PRODUCTS, INC. · U
- NATRELLE INSPIRA Single Use Sizers — Allergan · U
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc. · U
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc. · U
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc. · U
Cleared under the same submission
K010709 also covers:
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round High Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
- MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer — Mentor Texas LP
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 U | Pending data |
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Manufacturer
- Manufacturer
- Mentor Texas LP
Sources (1)
- FDA UDI 6ea4e61a-3ee2-447a-9711-fc2e37c3fbce 36 fields · synced May 31, 2026