FDA.reportPublic FDA data

Kensington Medical Holdings, LLC

Primary DI
00860005934638
Brand
Kensington Medical Holdings, LLC
Company
KENSINGTON MEDICAL HOLDINGS LLC
Model
FG14-CL
Device description
Flash-Guard 14 Clasp Lid
Published
2020-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K841669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K841669000FLASH GUARDSparco, Inc.1984-06-05

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005934638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005934638008600059346388600059346380860005934638

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
962502253
Device count
1
Lot or batch
true

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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