FDA.reportPublic FDA data

Kensington Medical Holdings, LLC

Primary DI
00860005934690
Brand
Kensington Medical Holdings, LLC
Company
KENSINGTON MEDICAL HOLDINGS LLC
Model
FG12-WB
Device description
Stainless Steel Wire Basket 254mm x 125mm
Published
2020-12-01
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
00860005934690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005934690008600059346908600059346900860005934690

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
00860005934614Kensington Medical Holdings, LLCFG20-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094696INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094702INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094719INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094658INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094665INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094672INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094580INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094597INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094603INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094610INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094627INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094634INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094641INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00850092212009SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729267STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729274STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729281SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729298VERSAPODContainmed, Inc.KCT2026-09-29
07392532290282Astra Tech Implant System EV Surgical Tray GSDentsply Implants Manufacturing GmbHKCT2026-09-29
07392532290299Astra Tech Implant System EV Surgical TrayDentsply Implants Manufacturing GmbHKCT2026-09-29
00385640094566INSTRUSAFESummit Medical, Inc.KCT2026-09-28
00385640094573INSTRUSAFESummit Medical, Inc.KCT2026-09-28
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24