FDA.reportPublic FDA data

Stainless Steel Cardiac 3 Finger Heart Retractor - Large

Primary DI
B354HAF3SHS2
Brand
Stainless Steel Cardiac 3 Finger Heart Retractor - Large
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
HAF3SHS
Device description
Stainless Steel Cardiac 3 Finger Heart Retractor - Heart Assist, Single Use, 3 Finger Short, Malleable 60mm x 54mm L
Published
2025-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101733000REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIESSac, LLC Dba Pinnacle Medical Surgical2011-06-06GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B354HAF3SHS2PrimaryHIBCC0
B35400Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Peracetic Acid

Regulatory Flags#

DUNS number
047063695
Device count
10
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B3543000011ThoraClear Y Connector3000-012025-11-25
B3543000012ThoraClear Y Connector3000-012025-11-25
B3543000013ThoraClear Y Connector3000-012025-11-25
B3543000014ThoraClear Y Connector3000-012025-11-25
B3543000015ThoraClear Y Connector3000-012025-11-25
B3543000019ThoraClear Y Connector3000-012025-11-25
B3543000010ThoraClear Y Connector3000-012025-11-25
B354OS3CDBK23 Ring Suture Passer - BariatricOS3CDBK2023-07-07
B354OS3CDBK33 Ring Suture Passer - BariatricOS3CDBK2023-07-07
B3541011Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541012Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541013Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541014Duck Bill Forceps Inner Shaft 10mm1012023-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06
B382SD13798330Surgical DirectSurgical Direct, Inc.GEI2026-10-06
00190776433284MillenniumAvalign Technologies, Inc.GEI2026-10-05
00848657078467AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657078474AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083782AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083812AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083843AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083874AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083898AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084963AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084970AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657087698AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25