| Primary Device ID | 16936603231125 | 
| NIH Device Record Key | 55031187-53d6-4eaa-867a-c4395be96508 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Bite Block | 
| Version Model Number | FTL-BB-AIII-W | 
| Catalog Number | SEN-BB | 
| Company DUNS | 544375774 | 
| Company Name | Yangzhou Fartley Medical Instrument Technology Co., Ltd | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 06936603231128 [Primary] | 
| GS1 | 16936603231125 [Package] Contains: 06936603231128 Package: Box [100 Units] In Commercial Distribution | 
| MNK | Endoscopic Bite Block | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-07-01 | 
| Device Publish Date | 2025-06-23 | 
| 16936603226909 - Disposable Endoscopy Valve Set | 2025-08-29 PENTAX i20 type: Cleaning Valve | 
| 16936603227944 - Single Use Cleaning Brush | 2025-07-15 | 
| 16936603230869 - Bedside Cleaning Sponge | 2025-07-01 Sentrus Cleaning Sponge, Sponge +enzymatic, tray | 
| 16936603230876 - Basic Bedside Kit | 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker | 
| 16936603230883 - Basic Bedside Kit | 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br | 
| 16936603230890 - Basic Bedside Kit | 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br | 
| 16936603230906 - Basic Bedside Kit | 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br | 
| 16936603230913 - Basic Bedside Kit | 2025-07-01 Sentrus Endoscopic Bedside Kit, Sponge +enzymatic, tray, guaze, lubricant, tranportation bag, and biohazard sticker, cleaning br | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BITE BLOCK  97079671  not registered Live/Pending | Keen Products Inc. 2021-10-18 | 
|  BITE BLOCK  90779029  not registered Live/Pending | Keen Products Inc. 2021-06-17 | 
|  BITE BLOCK  75200107  not registered Dead/Abandoned | National hearing Aid Distributors, Inc. 1996-11-19 | 
|  BITE BLOCK  75085590  2093688 Dead/Cancelled | SUN PHARMACEUTICALS CORP. 1996-04-09 |