FDA.reportPublic FDA data

HEART STABILIZER FINGER ATTACHMENT

Primary DI
00192896070301
Brand
HEART STABILIZER FINGER ATTACHMENT
Company
SONTEC INSTRUMENTS, INC.
Model
2800-828
Device description
HEARTLINE HEART STABILIZER FINGER ATTACHMENT 2S-TWO SHORT FINGERS (401-212S)
Published
2018-09-07
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
MWSStabilizer, Heart

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWSStabilizer, HeartCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B09928008280PreviousHIBCC0
00192896070301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896070301001928960703011928960703010192896070301

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
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00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07
00192896094567ROCHESTER CARMALT FORCEPS1100-150Q1100-150Q2019-03-07
00192896094758BLAKESLEY ETHMOID RONGEUR468-686468-6862019-03-07
00192896095861ETHMOID PEDIATRIC RONGEUR468-590Q468-590Q2019-03-25
00192896041028ETHMOID PEDIATRIC RONGEUR468-580468-5802018-09-10
00192896041035ETHMOID PEDIATRIC RONGEUR468-585468-5852018-09-11
00192896041042ETHMOID PEDIATRIC RONGEUR468-590468-5902018-09-10
00192896041059WILDE ETHMOID RONGEUR468-600468-6002018-09-10
00192896041066WILDE ETHMOID RONGEUR468-606468-6062018-09-11

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
04545499071699Tentacles NEOSB-KAWASUMI LABORATORIES, INC.MWS2019-11-15