| Primary Device ID | 00816020020238 |
| NIH Device Record Key | d672a13b-902b-4586-a347-62c4e6e10f52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chalgren |
| Version Model Number | 115-575-29TP |
| Catalog Number | 115-575-29TP |
| Company DUNS | 085932630 |
| Company Name | CHALGREN ENTERPRISES |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 408-847-3994 |
| sales@jarisupply.com | |
| Phone | 408-847-3994 |
| sales@jarisupply.com | |
| Phone | 408-847-3994 |
| sales@jarisupply.com |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816020020238 [Primary] |
| GS1 | 40816020020236 [Package] Package: Box [20 Units] In Commercial Distribution |
| IKT | Electrode, Needle, Diagnostic Electromyograph |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00816020020238]
Radiation Sterilization
[00816020020238]
Radiation Sterilization
[00816020020238]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-11 |
| Device Publish Date | 2016-09-09 |
| 00816020021174 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 120 inch Coated Leadwire (Assorted Colo |
| 00816020021167 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 96 inch Coated Leadwire (Assorted Color |
| 00816020021150 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 120 inch Coated Leadwire (Assorted Colors |
| 00816020021143 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 96 inch Coated Leadwire (Assorted Colors) |
| 00816020021136 | 10mm (0.39") Gold Plated Discs 3.04 m (120") Twisted Leadwire w/TP Conn |
| 00816020021129 | Reusable Disc Electrodes, EEG, 10 mm Silver Plated Discs, 120 inch PVC Leadwire (Assorted Colors |
| 00816020021112 | Reusable Disc Electrodes, EEG, 10 mm Gold Plated Discs, 120 inch PVC Leadwire (Assorted Colors) |
| 00816020021020 | Reusable Disc Electrodes, EEG, Gold Plated Discs, 120 inch Twisted Leadwire |
| 00816020021013 | Reusable Disc Electrodes, EEG, Gold Plated Discs, 96 inch Twisted Leadwire |
| 00816020021006 | Reusable Disc Electrodes, EEG, Gold Plated Discs, 72 inch Twisted Leadwire |
| 00816020020993 | Reusable Disc Electrodes, EEG, Gold Plated Discs, 60 inch Twisted Leadwire |
| 00816020020986 | Reusable Disc Electrodes, EEG, Gold Plated Discs, 48 inch Twisted Leadwire |
| 00816020020948 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 96 inch PVC Leadwire (Assorted Colors) |
| 00816020020931 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 72 inch PVC Leadwire (Assorted Colors) |
| 00816020020924 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 60 inch PVC Leadwire (Assorted Colors) |
| 00816020020917 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 48 inch PVC Leadwire (Assorted Colors) |
| 00816020020900 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 96 inch PVC Leadwire (Assorted Colors) |
| 00816020020894 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 72 inch PVC Leadwire (Assorted Colors) |
| 00816020020887 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 60 inch PVC Leadwire (Assorted Colors) |
| 00816020020870 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 48 inch PVC Leadwire (Assorted Colors) |
| 00816020020863 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 72 inch Coated Leadwire (Assorted Color |
| 00816020020856 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 60 inch Coated Leadwire (Assorted Color |
| 00816020020849 | Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 48 inch Coated Leadwire (Assorted Color |
| 00816020020832 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 72 inch Coated Leadwire (Assorted Colors) |
| 00816020020825 | Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 60 inch Coated Leadwire (Assorted Colors) |
| 00816020020818 | Reusable Finger Clip Electrode, EMG, 48 inch Shielded Leadwire |
| 00816020020801 | Reusable Finger Clip Electrode, EMG, 36 inch Shielded Leadwire |
| 00816020020795 | Reusable Finger Clip Electrode, EMG, 48 inch Leadwire |
| 00816020020788 | Reusable Finger Clip Electrode, EMG, 24 inch Leadwire |
| 00816020020771 | Reusable Ring Electrode w/Slide Lock, EMG, 48 inch Shielded Leadwire |
| 00816020020764 | Reusable Ring Electrode w/Slide Lock, EMG, 36 inch Shielded Leadwire |
| 00816020020757 | Reusable Ring Electrode w/Slide Lock, EMG, 48 inch Leadwire |
| 00816020020740 | Reusable Ring Electrode w/Slide Lock, EMG, 24 inch Leadwire |
| 00816020020733 | Reusable Ring Electrode, EMG, 48 inch Shielded Leadwire |
| 00816020020726 | Reusable Ring Electrode, EMG, 36 inch Shielded Leadwire |
| 00816020020719 | Reusable Ring Electrode, EMG, 48 inch Leadwire |
| 00816020020702 | Reusable Ring Electrode, EMG, 24 inch Leadwire |
| 00816020020696 | Reusable Ground Electrode, EMG, 32 mm Nickel Plated Disc w/Banana Plug Connector |
| 00816020020689 | Reusable Ground Electrode, EMG, 32 mm Nickel Plated Disc w/Banana Plug Connector |
| 00816020020672 | Reusable Ground Electrode, EMG, 32 mm Nickel Plated Disc |
| 00816020020665 | Reusable Ground Electrode, EMG, 32 mm Nickel Plated Disc |
| 00816020020658 | Reusable 30 mm Bar Electrode, EMG, 9 mm Convex Stainless Steel Discs |
| 00816020020641 | Reusable 30 mm Bar Electrode, EMG, 9 mm Convex Stainless Steel Discs |
| 00816020020634 | Reusable 30 mm Bar Electrode, EMG, 9 mm Concave Tin Discs, Shielded Leadwire |
| 00816020020627 | Reusable 30 mm Bar Electrode, EMG, 9 mm Concave Tin Discs |
| 00816020020610 | Reusable 30 mm Bar Electrode, EMG, 9 mm Concave Tin Discs |
| 00816020020603 | Reusable Paired Disc Electrode, EMG, 9 mm Tin Discs, Shielded Leadwire |
| 00816020020597 | Reusable Paired Disc Electrode, EMG, 9 mm Silver Discs, Shielded Leadwire |
| 00816020020580 | Reusable Paired Disc Electrode, EMG, 9 mm Gold Discs, Shielded Leadwire |
| 00816020020573 | Reusable Paired Disc Electrode, EMG, 9 mm Tin Discs |