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Shaped Breast Implant Sizer, Oval Base, Moderate Projection
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- Shaped Breast Implant Sizer, Oval Base, Moderate Projection FDA UDI
- Generic Name
- Invasive breast implant sizer, fixed, single-use FDA UDI
- Device Name
- Single Use Sterile Saline Breast Implant Sizer, Shaped, Oval Base, Moderate Projection, Footprint Based on Sientra Style 20645MP Implant, 370cc FDA UDI
- Model / Reference
- SZ20645-370MP FDA UDI
- Description
- Single Use Sterile Saline Breast Implant Sizer, Shaped, Oval Base, Moderate Projection, Footprint Based on Sientra Style 20645MP Implant, 370cc FDA UDI
Identifiers
- Catalog Number
- SZ20645-370MP FDA UDI
- Primary DI / UDI-DI
- M746SZ20645370MP0 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Invasive breast implant sizer, fixed, single-use
Shaped Breast Implant Sizer, Oval Base, Moderate Projection by Specialty Surgical Products, Inc. — Class U — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Invasive breast implant sizer, fixed, single-use.
- OPUS Silicone Gel Breast Implant Sizer — Sientra, Inc. · U
- MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile — Mentor Texas LP · U
- NATRELLE INSPIRA Single Use Sizers — Allergan · 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
- NATRELLE INSPIRA Single Use Sizers — Allergan · U
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
- Specialty Surgical Products, Inc.
Sources (1)
- FDA UDI 547ebd56-8daf-4d35-897f-8f9fa84d4fa8 35 fields · synced May 30, 2026