| 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 |
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| 00761059352921 - Unifine Pentips | 2024-01-30 Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G |
| 00384707001035 - Unistik VacuFlip | 2023-10-16 Unistik VacFlip, 20G Safety Needle 1" |
| 00384707102039 - Unistik VacuFlip | 2023-10-16 Unistik VacuFlip, 21G safety needle 1" with holder |
| 00384707117033 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer 8" tubing |
| 00384707122037 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer and holder 12" tubing |
| 00384707312032 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 23G Safety Winged Sets w/ Luer 12" tubing |
| 00384707317037 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 23G Safety Winged Set w/ Luer 8" tubing |