FDA.reportPublic FDA data

CASE MEDICAL

Primary DI
00653159014116
Brand
CASE MEDICAL
Company
Case Medical Inc.
Model
PC9017
Catalog number
PC9017
Device description
Reprocessing Tray for Laparoscopes, Light Guide Cable
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653159014116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653159014116006531590141166531590141160653159014116

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053057972
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653159014208CASE MEDICAL185008018500802026-06-08
00653159014215CASE MEDICAL185008118500812026-06-08
00653159014222CASE MEDICAL185008218500822026-06-08
00653159014239CASE MEDICAL185008318500832026-06-08
00653159014246CASE MEDICAL185008418500842026-06-08
00653159014253CASE MEDICAL185008518500852026-06-08
00653159014260CASE MEDICAL185009018500902026-06-08
00653159014277CASE MEDICAL185009118500912026-06-08
00653159014284CASE MEDICAL185009218500922026-06-08
00653159013232CASE MEDICAL973653197365312026-03-20
00653159013256CASE MEDICAL973653097365302026-03-20
00653159014062CASE MEDICAL973652997365292026-03-20
00653159014086CASE MEDICAL973652497365242026-03-20
00653159014123CASE MEDICAL973652397365232026-03-20
00653159014727CASE MEDICAL973652697365262026-03-20
00653159014734CASE MEDICAL973652797365272026-03-20
00653159014741CASE MEDICAL973652597365252026-03-20
00653159014987CASE MEDICAL973653497365342026-03-20
00653159015007CASE MEDICAL973652897365282026-03-20
00653159015182CASE MEDICAL973663297366322026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
00840456201923JMUJMU DENTAL, INCFRG2026-06-05
00840456201930JMUJMU DENTAL, INCFRG2026-06-05
00840456201947JMUJMU DENTAL, INCFRG2026-06-05
00840456202951JMUJMU DENTAL, INCFRG2026-06-05
00840456202968JMUJMU DENTAL, INCFRG2026-06-05
00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
00840456207208JMUJMU DENTAL, INCFRG2026-06-05
00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05