FDA.report

SPRI BASKETS (Single Frame), 600x300x100 MM

Primary DI
G006DJ60320
Brand
SPRI BASKETS (Single Frame), 600x300x100 MM
Company
DAUD JEE MFG. CO
Model
DJ6032
Catalog number
DJ6032
Device description
FOR HOLDING INSTRUMENTS DURING STERILIZATION.
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LRPTray, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G006DJ60320PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
645508946
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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G006DJ23440FULL MICRO PERFORATED TRAYS WITH LID 70x70x30MMDJ2344DJ23442022-12-23
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G006DJ23460FULL MICRO PERFORATED TRAYS WITH LID 80x40x30MMDJ2346DJ23462022-12-23
G006DJ23470FULL MICRO PERFORATED TRAYS WITH LID 80x80x34MMDJ2347DJ23472022-12-23
G006DJ23480FULL MICRO PERFORATED TRAYS WITH LID 80x80x40MMDJ2348DJ23482022-12-23

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