| Primary Device ID | 00849593009690 | 
| NIH Device Record Key | 8a83660a-d26d-4859-af65-cab9a091c631 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | UltraPoint | 
| Version Model Number | NM-016384 | 
| Company DUNS | 080242300 | 
| Company Name | AMC | 
| Device Count | 25 | 
| 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 | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | |
| Phone | 954-345-9800 | 
| info@advantagemed.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00849593009683 [Unit of Use] | 
| GS1 | 00849593009690 [Primary] | 
| IKT | Electrode, Needle, Diagnostic Electromyograph | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-04-24 | 
| Device Publish Date | 2019-04-16 | 
| 00849593009737 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE BL | 
| 00849593009669 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE OR | 
| 00849593009812 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 75 MM NEEDLE, 2 FT. (0.6 M) SINGLE GR | 
| 00849593009799 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE GR | 
| 00849593009775 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE GR | 
| 00849593009751 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE BL | 
| 00849593009713 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 25 MM NEEDLE, 2 FT. (0.6 M) SINGLE BL | 
| 00849593009690 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 45 MM NEEDLE, 2 FT. (0.6 M) SINGLE OR | 
| 00849593009652 | DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 29 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE RE | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ULTRAPOINT  88633744  not registered Live/Pending | Sulzer Mixpac AG 2019-09-27 | 
|  ULTRAPOINT  77768330  3746423 Dead/Cancelled | Norma Tropiano 2009-06-25 | 
|  ULTRAPOINT  77457066  3668309 Dead/Cancelled | B.E. Meyers & Company, Inc. 2008-04-24 | 
|  ULTRAPOINT  75656657  2388697 Live/Registered | O. MUSTAD & SON AMERICAS, INC. 1999-03-10 |