FDA.report

CASE MEDICAL

Primary DI
00653159010347
Brand
CASE MEDICAL
Company
CASE MEDICAL INC.
Model
ELEVRTRAY
Catalog number
ELEVRTRAY
Device description
UROLOGY RESECTION TRAY
Published
2021-02-09
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

Related Records

Product Codes

CodeName
FRGWrap, Sterilization

Product Code Classifications

CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653159010347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653159010347006531590103476531590103470653159010347

GMDN Terms

TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical 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 for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
053057972
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

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00653159017018CASE MEDICALKSZ-39312C-R2KSZ-39312C-R22026-01-29

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