FDA.reportPublic FDA data

ArthroFree® 2 Operating Room Kit

Primary DI
00850045863036
Brand
ArthroFree® 2 Operating Room Kit
Company
Lazurite Holdings LLC
Model
AF0116-101
Catalog number
ARTH-0006
Device description
Operating room kit for use with the ArthroFree® 2 Wireless Surgical Camera System.
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213860000ArthroFree Wireless Surgical Camera SystemLazurite Holdings, LLC2022-03-23GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045863036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045863036008500458630368500458630360850045863036

GMDN Terms#

Term, Definition table
TermDefinition
Video camera surgical microscope systemAn assembly of noninvasive devices intended to transmit detailed, magnified, video images from a surgical site (non-specific) to a monitor to facilitate visualization of the surgical site by the surgeon; it may include recording equipment for teaching applications. It typically includes a fibreoptic telescope, illumination hardware, video camera, positioning arm, appropriate hardware/cabling, and may include recording unit, monitor and transportation cart.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
833.214.2324Patrick@lazurite.co

Regulatory Flags#

DUNS number
088448366
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045863012ArthroFree® 2 ReceiverAF0002-101-122026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadAF0001-101-12ARTH-00132026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetAF0117-101ARTH-00112026-07-10
00860001744255Lazurite Holdings LLC ArthroFree Operating Room KitAF0013-101-112022-06-05
00850045863005Lazurite Holdings LLC ArthroFree Sterilization Tray KitAF0030-101-102022-09-14
00860001744279Lazurite Holdings LLC ArthroFree Receiver KitAF0028-101-102022-09-14
00860001744286Lazurite Holdings LLC ArthroFree Battery Charger KitAF0029-101-102022-09-14
00860001744293Lazurite Holdings LLC ArthroFree Sterilization Tray KitAF0030-101-102022-09-14
00860001744200Lazurite Holdings LLC Wireless Camera HeadAF0001-101-102022-06-05
00860001744217Lazurite Holdings LLC Sterilization TrayAF0005-101-102022-06-05
00860001744224Lazurite Holdings LLC BatteryAF0003-101-102022-06-05
00860001744231Lazurite Holdings LLC Battery ChargerAF0004-101-102022-06-05
00860001744248Lazurite Holdings LLC ReceiverAF0002-101-102022-06-05
00860001744262Lazurite Holdings LLC ArthroFree Additional Camera KitAF0014-101-102022-06-05
10860001744221Lazurite Holdings LLC ArthroFree Battery SetAF0015-101-102022-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18