FDA.reportPublic FDA data

Tray

Primary DI
G284NN01
Brand
Tray
Company
Neurovention LLC
Model
NN-01
Device description
Instrument and Device Tray. Includes parts NN-01-CD-01 Caddy, NN-01-CD-02 Caddy Lid, NN-01-CS Implant and Caddy Sterilization Tray, and NN-01-CV Tray Lid
Published
2022-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OJGNeurological Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G284NN01PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
074912476
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
G28424104Screw T6 Torx241-042025-05-12
G28433305Screwdriver Bit Torx333-052025-05-12
G2843520100Drill Bit352-01-002024-10-17
G284241019Screw Torx Slot241-012022-09-09
G28424101Screw Torx Slot241-012022-06-21
G28435101Rescue Screw Torx Slot351-012022-06-21
G28433302Screwdriver Bit Torx Slot333-022022-06-22
G28433001NuCrani Small Plate330-012022-06-21
G28433301Screwdriver Bit Torx333-012022-06-21
G28435201Drill Bit352-012022-06-21
G28435301Screwdriver353-012022-06-21
G28436102NuCrani Large Plate361-022022-06-21
G28437801Screwdriver Spanner378-012022-06-21
G28440901KTC Burr Hole Cover409-012022-06-21
G28441001KTC Burr Hole Cover410-012022-06-21

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Primary DI, Brand, Company table
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