FDA.reportPublic FDA data

16 Channel Breast SatPad™

Primary DI
00850004813140
Brand
16 Channel Breast SatPad™
Company
Sat Pad Inc.
Model
1
Catalog number
100014
Device description
16 Channel Breast , Radiological Positioning device for MR
Published
2019-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K926416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K926416000SAT PAD(TM)Alliance Pharmaceutical Corp.1993-05-19LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004813201PackageGS11In Commercial Distribution
00850004813140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004813201008500048132018500048132010850004813201
00850004813140008500048131408500048131400850004813140

GMDN Terms#

Term, Definition table
TermDefinition
Radiological breast positioner, non-wearableA device that is specifically designed to ensure adequate positioning and immobilization of the female patient's breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad (non-wearable device) and may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
667-225-2721pat@satpads.com

Regulatory Flags#

DUNS number
081347868
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004813263 Breast Pad Insert H SatPad™11000162019-12-12
00850004813256 Breast Pad Insert SatPad™11000182019-06-18
10850004813253 Breast Pad Insert SatPad™11000182019-06-18
00850004813027Ankle/Foot SatPad™11000032019-04-02
00850004813041Knee SatPad™11000052019-04-02
00850004813058Neck SatPad™11000022019-04-02
00850004813072Ankle Toe Cap SatPad™11000072019-04-02
00850004813089Shoulder SatPad™11000082019-04-02
00850004813102Brachial Plexus SatPad™11000102019-04-02
00850004813225Ankle/Foot & Toe Cap SatPad™ Set12000152019-04-02
00850004813249Neck & Brachial Plexus SatPad™ Set12000182019-04-02
00850004813065Back/Abdomen SatPad™11000062019-04-02

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Primary DI, Brand, Company table
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08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
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08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
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