FDA.reportPublic FDA data

Breast Pad Insert SatPad™

Primary DI
10850004813253
Brand
Breast Pad Insert SatPad™
Company
Sat Pad Inc.
Model
1
Catalog number
100018
Device description
Breast Pad Insert Sat Pad™ , Radiological Positioning device for MR
Published
2019-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10850004813253PackageGS11In Commercial Distribution
00850004813256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000481325310850004813253
00850004813256008500048132568500048132560850004813256

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
0085000481314016 Channel Breast SatPad™11000142019-04-02
00850004813225Ankle/Foot & Toe Cap SatPad™ Set12000152019-04-02
00850004813249Neck & Brachial Plexus SatPad™ Set12000182019-04-02
00850004813065Back/Abdomen SatPad™11000062019-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
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
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
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09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19
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