FDA.reportPublic FDA data

CASE MEDICAL

Primary DI
00653159007583
Brand
CASE MEDICAL
Company
CASE MEDICAL INC.
Model
KSZ-39311AS
Catalog number
KSZ-39311AS
Device description
CONTAINER, 4 RIGID SCOPES (4MM X 18CM)
Published
2016-09-15
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

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
00653159007583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653159007583006531590075836531590075830653159007583

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
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

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
00634916099225INSTRUMENT COVERSTANDARD TEXTILE CO., INC.FRG2026-03-11
10810132809986House Brand DentistryFrontier Dental Supply IncFRG2026-02-13
00810194400810AiraAIRA, LLCFRG2026-02-10
00810194400841AiraAIRA, LLCFRG2026-02-10
00810194400858AiraAIRA, LLCFRG2026-02-10
00810194400902AiraAIRA, LLCFRG2026-02-10
00810194400919AiraAIRA, LLCFRG2026-02-10
00810194400926AiraAIRA, LLCFRG2026-02-10
00810194400940AiraAIRA, LLCFRG2026-02-10
00810194400971AiraAIRA, LLCFRG2026-02-10
00810194400995AiraAIRA, LLCFRG2026-02-10
D8305514332MEDICOMAMD Medicom IncFRG2026-02-10
06438263667267Steriking®Wipak OyFRG2026-02-02
06438263667274Steriking®Wipak OyFRG2026-02-02
06438263667281Steriking®Wipak OyFRG2026-02-02
10197344148967MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-23
10197344174454MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-23
40080196752738MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-22
40080196752745MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-22
40080196752707MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-21
00810194400896AiraAIRA, LLCFRG2026-01-16
00810194400933AiraAIRA, LLCFRG2026-01-16
00810194400964AiraAIRA, LLCFRG2026-01-16
06438263667250Steriking®Wipak OyFRG2025-12-30
06438263620378Steriking®Wipak OyFRG2025-12-30
06438263660640Steriking®Wipak OyFRG2025-12-30
06438263620392Steriking®Wipak OyFRG2025-12-30
06438263620408Steriking®Wipak OyFRG2025-12-30
06438263620415Steriking®Wipak OyFRG2025-12-30
06438263620422Steriking®Wipak OyFRG2025-12-30