Kensington Medical Holdings, LLC

GUDID 00860000950077

Flash-Guard 23 with Stainless Steel Dome Lid, Universal Handle, and Instrument Rack

KENSINGTON MEDICAL HOLDINGS LLC

Sterilization/disinfection container

• Primary Device ID: 00860000950077
• NIH Device Record Key: bf011084-e690-4172-8c5f-4cb98569f073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kensington Medical Holdings, LLC
• Version Model Number: FG23-D
• Company DUNS: 962502253
• Company Name: KENSINGTON MEDICAL HOLDINGS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000950077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K841669

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-10
• Device Publish Date: 2020-12-02

On-Brand Devices [Kensington Medical Holdings, LLC]

• 00860000950046: Flash Guard Sterilization Container 14"
• 00860000950039: Flash Guard Sterilization Container 23"
• 00860000950022: Flash Guard Sterilization Container 12"
• 00860000950008: Flash Guard Sterilization Container 20"
• 00860005968633: Stainless Steel Insert Basket for Flash-Guard 12"
• 00860005934690: Stainless Steel Wire Basket 254mm x 125mm
• 00860005934669: Stainless Steel Instrument Rack 254mm x 178mm
• 00860005934652: Stainless Steel Instrument Rack 254mm x 121mm
• 00860000950077: Flash-Guard 23 with Stainless Steel Dome Lid, Universal Handle, and Instrument Rack
• 00860000950015: Flash-Guard 12 with Poly Lid and Universal Handle
• 00860005934645: Flash-Guard 20 Clasp Lid
• 00860005934638: Flash-Guard 14 Clasp Lid
• 00860005934621: Flash-Guard 12 Clasp Lid
• 00860005934614: Flash-Guard 20 with SS Clasp Lid, Universal Handle, and Instrument Rack
• 00860005934607: Flash-Guard 14 with SS Clasp Lid, Universal Handle, and Instrument Rack
• 00860000950084: Flash-Guard 12 with SS Clasp Lid, Universal Handle, and Instrument Rack
• 00860000950060: Flash-Guard 20 with Poly Lid and Universal Handle
• 00860000950053: Flash-Guard 14 with Poly Lid and Universal Handle
• 00860005968664: Stainless Steel Insert Basket for Flash-Guard 23"
• 00860005968657: Stainless Steel Insert Basket for Flash-Guard 20"
• 00860005968640: Stainless Steel Insert Basket for Flash-Guard 14"
• 00860005968626: Stainless Steel Wire Basket 533mm x 285mm
• 00860005968619: Stainless Steel Wire Basket 419mm x 250mm
• 00860005968602: Stainless Steel Wire Basket 254mm x 178mm
• 00860005934683: Stainless Steel Instrument Rack 533mm x 285mm
• 00860005934676: Stainless Steel Instrument Rack 419mm x 250mm
• 00860000950091: Universal Handle