Identity
- Trade Name
- Breast Pad Insert H SatPad™ FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Device Name
- Breast Pad Insert Sat Pad™ , Radiological Positioning device for MR FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Breast Pad Insert Sat Pad™ , Radiological Positioning device for MR FDA UDI
Identifiers
- Catalog Number
- 100016 FDA UDI
- Primary DI / UDI-DI
- 00850004813263 FDA UDI
- 510(k) Number
- K926416 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Radiological breast positioner, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological breast positioner, non-wearable
Breast Pad Insert H SatPad™ by Sat Pad Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological breast positioner, non-wearable.
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- C-Qual™ — Medtec LLC · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Positioning Cushion — Medtec LLC · Class II
- SenoView Prone Breast Board — Aktina Corp. · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Monarch™ Overhead Arm Positioner — Medtec LLC · Class II
- C-Qual™ — Medtec LLC · Class II
Cleared under the same submission
K926416 also covers:
- 16 Channel Breast SatPad™ — Sat Pad Inc.
- Ankle Toe Cap SatPad™ — Sat Pad Inc.
- Ankle/Foot & Toe Cap SatPad™ Set — Sat Pad Inc.
- Ankle/Foot SatPad™ — Sat Pad Inc.
- Back/Abdomen SatPad™ — Sat Pad Inc.
- Brachial Plexus SatPad™ — Sat Pad Inc.
- Breast Pad Insert SatPad™ — Sat Pad Inc.
- Knee SatPad™ — Sat Pad Inc.
- Neck & Brachial Plexus SatPad™ Set — Sat Pad Inc.
- Neck SatPad™ — Sat Pad Inc.
- Shoulder SatPad™ — Sat Pad Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sat Pad Inc.
Sources (1)
- FDA UDI 361bcedc-c7cf-4ae4-b493-1fed798ff202 36 fields · synced May 30, 2026