FDA.reportPublic FDA data

Tentacles NEO

Primary DI
04545499071699
Brand
Tentacles NEO
Company
SB-KAWASUMI LABORATORIES, INC.
Model
MD-27320A
Device description
This Product is a device used as a heart positioner particularly for Off-Pump CABG (Coronary Artery Bypass Grafting). Three (3) Suction Cups are attached to the surface of the heart by means of suction pressure applied to each one of them. Traction Tubes are pulled and clamped to the surgical drape by Forceps in order to fix the position of the heart.
Published
2019-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MWSStabilizer, Heart

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWSStabilizer, HeartCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24545499071693PackageGS11In Commercial Distribution
04545499071699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2454549907169324545499071693
04545499071699045454990716994545499071699

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, single-useA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.

Regulatory Flags#

DUNS number
690625850
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04545499074423SB Knife Jr2MD-477022026-04-06
04545499074430SB Knife Jr2 /Long typeMD-47702L2026-04-06
00646311400018WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-21GDBM1-21G2016-09-20
00646311400025WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-23GDBM1-23G2016-09-20
00646311400032WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-25GDBM1-25G2016-09-20
00646311410017SMALL VEIN INFUSION SETD3K1-21G1D3K1-21G12016-09-20
00646311410024SMALL VEIN INFUSION SETD3K1-23G1D3K1-23G12016-09-20
00646311410031SMALL VEIN INFUSION SETD3K1-25G1D3K1-25G12016-09-20
00646311410055SMALL VEIN INFUSION SETD3K2-19GD3K2-19G2016-09-20
00646311410062SMALL VEIN INFUSION SETD3K2-20GD3K2-20G2016-09-20
00646311410079SMALL VEIN INFUSION SETD3K2-21GD3K2-21G2016-09-20
00646311410086SMALL VEIN INFUSION SETD3K2-22GD3K2-22G2016-09-20
00646311410093SMALL VEIN INFUSION SETD3K2-23GD3K2-23G2016-09-20
00646311410109SMALL VEIN INFUSION SETD3K2-24GD3K2-24G2016-09-20
00646311410116SMALL VEIN INFUSION SETD3K2-25GD3K2-25G2016-09-20
00646311410123SMALL VEIN INFUSION SETD3K2-27GD3K2-27G2016-09-20
00646311410482K-SHIELD ADVANTAGE SMALL VEIN INFUSION SETD3KA-19GD3KA-19G2016-09-20
00646311410505K-SHIELD ADVANTAGE SMALL VEIN INFUSION SETD3KA-27GD3KA-27G2016-09-20
04987488104139K-Shield Advantage Blood Drawing KitBK-64ABK-64A2024-12-24
04987488104146INTERMITTENT INJECTION SITEINT-01INT-012024-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000446239Starfish™ EvoMEDTRONIC, INC.MWS2026-04-24
00763000446246Urchin™ EvoMEDTRONIC, INC.MWS2026-04-24
00643169668980STARFISH® EVOMEDTRONIC, INC.MWS2025-05-30
10840199536648Stabilizer ClampKOROS U.S.A., INC.MWS2024-01-31
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
00192896108509Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2021-04-08
04046955051984SHAMROCKFLEXAesculap AGMWS2021-04-05
00699753450844Titan Flex StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
00699753450851Titan Flex 360 StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
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
10080196341382MedlineMEDLINE INDUSTRIES, INC.MWS2021-01-20
40080196341383MedlineMEDLINE INDUSTRIES, INC.MWS2021-01-20
00763000284800Octopus™MEDTRONIC, INC.MWS2020-10-30
04046964828782HEARTPADAesculap AGMWS2020-08-24
04545499071194TentaclesSB-KAWASUMI LABORATORIES, INC.MWS2020-05-26
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