FDA.reportPublic FDA data

Kensington Medical Holdings, LLC

Primary DI
00860005934614
Brand
Kensington Medical Holdings, LLC
Company
KENSINGTON MEDICAL HOLDINGS LLC
Model
FG20-C
Device description
Flash-Guard 20 with SS Clasp Lid, Universal Handle, and Instrument Rack
Published
2020-12-03
Public version status
Update
Distribution status
Not 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
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005934614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005934614008600059346148600059346140860005934614

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.

Regulatory Flags#

DUNS number
962502253
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
false
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
00860000950091Kensington Medical Holdings, LLCFG-172020-11-18
00860005934676Kensington Medical Holdings, LLCFG20-IR2020-12-14
00860005934683Kensington Medical Holdings, LLCFG23-IR2020-12-14
00860005968602Kensington Medical Holdings, LLCFG14-WB2020-12-14
00860005968619Kensington Medical Holdings, LLCFG20-WB2020-12-14
00860005968626Kensington Medical Holdings, LLCFG23-WB2020-12-14
00860005968640Kensington Medical Holdings, LLCFG14-IWBS2020-12-14
00860005968657Kensington Medical Holdings, LLCFG20-IWBS2020-12-14
00860005968664Kensington Medical Holdings, LLCFG23-IWBS2020-12-14
00860000950053Kensington Medical Holdings, LLCFG14-P2020-12-03
00860000950060Kensington Medical Holdings, LLCFG20-P2020-12-03
00860000950084Kensington Medical Holdings, LLCFG12-C2020-12-03
00860005934607Kensington Medical Holdings, LLCFG14-C2020-12-03
00860005934621Kensington Medical Holdings, LLCFG12-CL2020-12-03
00860005934638Kensington Medical Holdings, LLCFG14-CL2020-12-03
00860005934645Kensington Medical Holdings, LLCFG20-CL2020-12-03
00860000950015Kensington Medical Holdings, LLCFG12-P2020-12-02
00860000950077Kensington Medical Holdings, LLCFG23-D2020-12-02
00860005934652Kensington Medical Holdings, LLCFG12-IR2020-12-01
00860005934669Kensington Medical Holdings, LLCFG14-IR2020-12-01

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Primary DI, Brand, Company table
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