| Primary Device ID | 00860005934614 |
| NIH Device Record Key | 7c1f64f4-8c21-4b9f-95a5-37a0f6beedaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kensington Medical Holdings, LLC |
| Version Model Number | FG20-C |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005934614 [Primary] |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-11 |
| Device Publish Date | 2020-12-03 |
| 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 |