FDA.reportPublic FDA data

CASE MEDICAL

Primary DI
00653159002250
Brand
CASE MEDICAL
Company
Case Medical Inc.
Model
SC04H
Catalog number
SC04H
Device description
"STERITITE SEALED CONTAINER W/LID HALF SIZE SOLID BOTTOM (12.3""X11""X4""H)"
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653159002250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653159002250006531590022506531590022500653159002250

GMDN Terms#

Term, Definition table
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 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
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
00653159015229CASE MEDICAL973663397366332026-03-20
00653159013751CASE MEDICALKSZ-39301TSKSZ-39301TS2026-02-03
00653159012709CASE MEDICALBR10-092BR10-0922026-01-29
00653159016967CASE MEDICALKSZ-39312FESS-R2KSZ-39312FESS-R22026-01-29
00653159016974CASE MEDICALKSZ-39312FESS-R3KSZ-39312FESS-R32026-01-29
00653159016981CASE MEDICALKSZ-39312FESS-R4KSZ-39312FESS-R42026-01-29
00653159016998CASE MEDICALKSZ-39301LTA-RKSZ-39301LTA-R2026-01-29
00653159017001CASE MEDICALKSZ-39312C-R1KSZ-39312C-R12026-01-29
00653159017018CASE MEDICALKSZ-39312C-R2KSZ-39312C-R22026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
08404535029437Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
08404535025927Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-01
08404535015003Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535019100Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025217Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025248Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025279Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178506MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178513MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178568MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15