FDA.reportPublic FDA data

3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs

Primary DI
B354OS3CDBKS0
Brand
3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
OS3CDBKS
Catalog number
OS3CDBKS
Device description
3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs
Published
2021-01-11
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
GCJLaparoscope, General & Plastic Surgery
GEIElectrosurgical, Cutting & Coagulation & Accessories
HIFInsufflator, Laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

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
B354OS3CDBKS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic wound closure threadA sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047063695
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B354OSCVORTH80Tube HolderOSCVORTH82026-10-19
B354OSCVORTH81Tube HolderOSCVORTH82026-10-19
B354OSCVORTH82Tube HolderOSCVORTH82026-10-19
B354OSCVORTH83Tube HolderOSCVORTH82026-10-19
B354OSCVORTH84Tube HolderOSCVORTH82026-10-19
B354OSCVORTH85Tube HolderOSCVORTH82026-10-19
B354OSCVORTH89Tube HolderOSCVORTH82026-10-19
B354OSCVORTH0Cardiac Tube HolderOSCVORTH2016-11-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCHIF2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCHIF2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCHIF2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCHIF2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCHIF2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCHIF2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCHIF2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19