FDA.reportPublic FDA data

ActivSight Laparoscope Sterilization Tray

Primary DI
00850016403193
Brand
ActivSight Laparoscope Sterilization Tray
Company
Activ Surgical, Inc.
Model
AS-SCT001
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016403193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016403193008500164031938500164031930850016403193

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Regulatory Flags#

DUNS number
079855777
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016403001ActivSight Light EngineAS-LE0012026-05-26
00850016403018Activ Sight C-Mount Imaging ModuleAS-IM0012026-05-26
00850016403025ActivSIght Light GuideAS-LC0012026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerAS-AD0012026-05-26
00850016403049ActivSight Imaging Module Clean and Disinfect TrayAS-IMT0022026-05-26
00850016403063ActivSight Light Cable Sterilization TrayAS-LCT0012026-05-26
00850016403070ActivSight Imaging Module Tray for VHPAS-IMT0012026-05-26
00850016403087ActivSight Light Cable Adapter - StorzAS-AD0022026-05-26
00850016403094ActivSight Integrated Imaging ModuleAS-IM0022026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRAS-AD0052026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRAS-AD0032026-05-26
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRAS-LAP5302026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRAS-LAP10302026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRAS-LAP502026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRAS-LAP1002026-05-26

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Primary DI, Brand, Company table
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00385640092456INSTRUSAFESummit Medical, Inc.KCT2026-08-07