FDA.report

CASE MEDICAL

Primary DI
00653159004100
Brand
CASE MEDICAL
Company
CASE MEDICAL INC.
Model
SCKIT1WN
Catalog number
SCKIT1WN
Device description
STANDARD H2O2 DISPOSABLE KIT
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
true

Related Records

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653159004100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653159004100006531590041006531590041000653159004100

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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00653159015007CASE MEDICAL973652897365282026-03-20
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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

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