FDA.reportPublic FDA data

Heartline Stabilizer Arm

Primary DI
00192896114449
Brand
Heartline Stabilizer Arm
Company
SONTEC INSTRUMENTS, INC.
Model
2800-814
Catalog number
2800-814
Device description
Heartline Stabilizer Arm Low Profile With Square Body
Published
2023-02-03
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
00192896114449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896114449001928961144491928961144490192896114449

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896012639ALGERBRUSH DIAMOND BURR11-461011-46102018-09-18
00192896012646ALGERBRUSH DIAMOND FINE GRIT BURR11-461111-46112018-09-18
00192896012653ALGERBRUSH DIAMOND BURR11-461211-46122018-09-18
00192896012660ALGERBRUSH DIAMOND BURR11-461311-46132018-09-18
00192896012677ALGERBRUSH DIAMOND BURR11-461411-46142018-09-18
00192896072398ALGERBRUSH DIAMOND BURR11-460911-46092018-09-19
00192896092792UNIVERSITY OF MINNESOTA CHEEK RETRACTOR207-210207-2102019-01-03
00192896044661BARR PROBE508-547508-5472018-09-14
00192896123397Smithwick Vasectomy Hook516-716516-7162026-05-12
00192896123373Skinner Tissue Forceps140-376H140-376H2026-05-11
00192896123380Biopsy Punch2901-117L2901-117L2026-05-11
00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
00192896118003Reynolds Tenotomy Scissors2405-329B2405-329B2024-06-21
00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03

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
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
24545499071693Tentacles NEOSUMITOMO BAKELITE COMPANY LIMITEDMWS2019-11-15