FDA.report

STARFISH® EVO

Primary DI
00643169668980
Brand
STARFISH® EVO
Company
MEDTRONIC, INC.
Model
HP3000
Device description
HEART POSITIONER HP3000 STARFISH EVO 26L
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MWSStabilizer, heart

Product Code Classifications

CodeDeviceSpecialtyClass
MWSStabilizer, HeartCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169668980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169668980006431696689806431696689800643169668980

GMDN Terms

TermDefinition
Patient positioning vacuum padA device designed to position and immobilize parts of the patient (e.g., head, extremities) typically during therapeutic interventions or patient transportation. The device immobilizes a body part by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the part that it encompasses until the vacuum is released.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
true
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

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00763000812133NABB12A69R12022-12-31
00763000812157NACB9E90R62022-12-31
00763000823580NAHY11W68R32023-01-14
00763000823597NAHY11N74R142023-01-14
00763000823795NAHY12A49R12023-01-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840199536641Stabilizer ClampKOROS U.S.A., INC.MWS2024-01-31
00192896114425Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2023-02-03
00192896114432Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2023-02-03
00192896114449Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2023-02-03
00192896112933Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2022-05-30
00763000543679OCTOPUS®MEDTRONIC, INC.MWS2021-07-18
00763000543686STARFISH™MEDTRONIC, INC.MWS2021-07-18
00763000543693OCTOPUS®MEDTRONIC, INC.MWS2021-07-18
00192896108509HL Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2021-04-08
04046955051984SHAMROCKFLEXAesculap AGMWS2021-04-05
50699753450849Titan Flex StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
50699753450856Titan Flex 360 StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
00699753450943Herc Flex 360 Universal Stabilizer Arm Terumo Cardiovascular Systems CorporationMWS2021-03-18
00699753450950Herc Flex Universal Stabilizer ArmTerumo Cardiovascular Systems CorporationMWS2021-03-18
40080196341383MedlineMEDLINE INDUSTRIES, INC.MWS2021-01-20
00763000284800Octopus™MEDTRONIC, INC.MWS2020-10-30
04046964828782HEARTPADAesculap AGMWS2020-08-24
04545499071194TentacleSUMITOMO BAKELITE COMPANY LIMITEDMWS2020-05-26
00607567500006Acrobat-i PositionerMAQUET CARDIOVASCULAR LLCMWS2020-04-27
00607567900004Acrobat SUV StabilizerMAQUET CARDIOVASCULAR LLCMWS2020-04-27
00192896100602HEARTLINE STABILIZER ARM CLAMPSONTEC INSTRUMENTS, INC.MWS2020-02-24
00607567100008Acrobat-I StabilizerMAQUET CARDIOVASCULAR LLCMWS2019-12-31
24545499071693Tentacles NEOSUMITOMO BAKELITE COMPANY LIMITEDMWS2019-11-15
24545499070832Tentacles NEOSUMITOMO BAKELITE COMPANY LIMITEDMWS2019-11-15
B09928008100STABILIZER ARMSONTEC INSTRUMENTS, INC.MWS2018-09-07
B09928008150STABILIZER TIPSSONTEC INSTRUMENTS, INC.MWS2018-09-07
B09928008180STABILIZER TIPSSONTEC INSTRUMENTS, INC.MWS2018-09-07
B09928008260HEART STABILIZER FINGER ATTACHMENTSONTEC INSTRUMENTS, INC.MWS2018-09-07
B09928008280HEART STABILIZER FINGER ATTACHMENTSONTEC INSTRUMENTS, INC.MWS2018-09-07
B09928008300HEART STABILIZER FINGER ATTACHMENTSONTEC INSTRUMENTS, INC.MWS2018-09-07