| Primary Device ID | 00038470310039 |
| NIH Device Record Key | 71024039-ae68-4432-b40a-117d7a685129 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amielle Restore |
| Version Model Number | SM 3100 |
| Company DUNS | 803401454 |
| Company Name | OWEN MUMFORD USA INCORPORATED |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00038470310039 [Package] Contains: 00384703100015 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 00384703100015 [Primary] |
| HDQ | Dilator, Cervical, Fixed Size |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-10-21 |
| Device Publish Date | 2022-09-15 |
| 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 |