FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515251014
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
95-9802
Catalog number
95-9802
Device description
"Jackson Asp Tube, open end, 2.5mm, 13 3/4"""
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KARIRRIGATOR, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KARIrrigator, SinusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515251014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515251014008885152510148885152510140888515251014

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags#

DUNS number
848522678
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
00888515202146BOSS Instruments77-322077-32202024-02-28
00888515328037BOSS InstrumentsVSX233VSX2332025-10-28
00888515328044BOSS InstrumentsVSG511VSG5112025-10-28
00888515272026Stealth SurgicalSS3923SS39232016-10-01
00888515272040Stealth SurgicalSS3925SS39252016-10-01
00888515272064Stealth SurgicalSS3927SS39272016-10-01
00888515217515BOSS Instruments80-624080-62402024-02-28
00888515217522BOSS Instruments80-624280-62422024-02-28
00888515217539BOSS Instruments80-624480-62442024-02-28
00888515217546BOSS Instruments80-624680-62462024-02-28
00888515217553BOSS Instruments80-624880-62482024-02-28
00888515217560BOSS Instruments80-625080-62502024-02-28
00888515217577BOSS Instruments80-625280-62522024-02-28
00888515217584BOSS Instruments80-625380-62532024-02-28
00888515217591BOSS Instruments80-625480-62542024-02-28
00888515217638BOSS Instruments80-626080-62602024-02-28
00888515217645BOSS Instruments80-626180-62612024-02-28
00888515217683BOSS Instruments80-627080-62702024-02-28
00888515217690BOSS Instruments80-627580-62752024-02-28
00888515217706BOSS Instruments80-627880-62782024-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978785665117InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665124InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665148InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665056InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-08-08
00194613022020MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022044MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022051MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022068MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022075MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022082MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00805106849603XTREMEXtreme Personal Care Inc.KAR2025-04-20
00194613022006MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022013MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022037MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022099MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00887482123874Symmetry ASPEN SURGICAL PRODUCTS, INC.KAR2024-08-15
00887482124970Symmetry JacksonASPEN SURGICAL PRODUCTS, INC.KAR2024-08-15
00888515244573BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515244597BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251038BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251045BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251052BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251076BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251120BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251137BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251144BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251151BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251175BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
G586E97332590Novo SurgicalNOVO SURGICAL, INC.KAR2023-12-18
00190776351953MillenniumAvalign Technologies, Inc.KAR2023-11-17