FDA.reportPublic FDA data

N/A

Primary DI
00613994728531
Brand
N/A
Company
MEDTRONIC NAVIGATION, INC.
Model
9734470
Device description
STARSHIELD 9734470 DISP FLOOR FOIL 5PK
Published
2016-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K032541000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032541000POLESTAR N-20Odin Medical Technologies , Ltd.2003-09-12LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994728535PackageGS15In Commercial Distribution
00613994728531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399472853520613994728535
00613994728531006139947285316139947285310613994728531

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency shielding materialA radiation protection device consisting of electrically conductive materials used in conjunction with other medical devices to form a barrier against radio-frequency (RF) emissions and interference. This kind of material protects medical devices and/or persons from incident or stray radio-frequency fields. This group of devices includes a wide variety of materials, e.g., copper (Cu) sheeting and copper mesh. Copper sheets and copper mesh are used in walls, floors, ceiling, doors and windows for magnetic resonance imaging rooms to prevent interference with the electronics used to form and receive the radio-frequency imaging pulses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835233107
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150054398StealthStation S897357622026-08-07
00199150054466N/A97367262026-08-08
00199150057078AXIS AP ROBOTIC TOOL CHANGER 973668197366812026-08-09
00199150067626KIT 9736691 SPINE REFERENCING97366912026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALL97364332026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUM97364652026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORT97364342026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUM97364672026-08-07
00763000381141N/A97314602026-08-08
00763000989927AXIS HYBRID REF FRAME 973651197365112026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 973651397365132026-08-07
00763000539238SteathStation97364262023-08-04
00763000539108SteathStation97364232022-02-07
00763000539177SteathStation97364262022-02-07
00763000914097Stealth AXiS97365032026-07-24
00763000914035Stealth AXiS97364812026-07-17
00763000914042Stealth AXiS97364822026-07-17
00763000914059Stealth AXiS97364832026-07-17
00763000914066Stealth AXiS97364842026-07-17
00763000914073Stealth AXiS97364852026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816396022676WGS-100 Respiration PillowIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023550WGS-100 Wireless Gating SystemIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023567WGS-100 TransmitterIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023574WGS-100 Base StationIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
07090042059091nordicAktivaNordicneurolab ASLNH2026-08-03
00866463000496STAGESpintech, Inc.LNH2026-07-23
04068151086584LungMapsSiemens Healthineers AGLNH2026-06-24
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
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
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12