| Primary Device ID | 00384702209016 | 
| NIH Device Record Key | 16e26cc0-dc25-483a-87dd-8b948d8016d0 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Rapport Rings - Size 9 | 
| Version Model Number | SM2209 | 
| Catalog Number | SM2209 | 
| Company DUNS | 803401454 | 
| Company Name | OWEN MUMFORD USA INCORPORATED | 
| 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 | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | true | 
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | |
| Phone | 770-977-2226 | 
| info@owenmumfordinc.com | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Lumen/Inner Diameter | 24 Millimeter | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00384702209016 [Primary] | 
| GS1 | 0384702209030 [Package] Package: Case [1 Units] In Commercial Distribution | 
| LKY | Device, External Penile Rigidity | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-09-19 | 
| 00384703160019 - Empelvic | 2025-09-08 Pelvic Floor Trainer - Femail | 
| 00384703150010 - Empelvic | 2025-09-01 Pelvic Floor Trainer - Femail | 
| 00384703155015 - Empelvic | 2025-09-01 Pelvic Floor Trainer - Male | 
| 00761059640028 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needle 4mm x 32G 100 ct | 
| 00761059641032 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needles 4mm x 32G 50 ct | 
| 00761059650027 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needle, 5mm x 31G, 100 ct | 
| 00761059651031 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needle, 5mm x 31G, 50 ct | 
| 00761059354024 - Unifine Pentips | 2024-02-13 Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G |