| Primary Device ID | 00810113682891 |
| NIH Device Record Key | e8843475-e070-4917-826a-dc472ceeaf49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManaEZ Ankle 06 Extra Small |
| Version Model Number | EZANKLE06XS |
| Catalog Number | EZANKLE06XS |
| Company DUNS | 084042331 |
| Company Name | Manamed, Inc. |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810113682891 [Primary] |
| ITW | Joint, Ankle, External Brace |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-06 |
| Device Publish Date | 2025-09-26 |
| 00810113682891 - ManaEZ Ankle 06 Extra Small | 2025-10-06The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion. |
| 00810113682891 - ManaEZ Ankle 06 Extra Small | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682907 - ManaEZ Ankle 06 Small | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682914 - ManaEZ Ankle 06 Medium | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682921 - ManaEZ Ankle 06 Large | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682938 - ManaEZ Ankle 06 Extra Large | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682945 - ManaEZ Ankle 06 Extra Extra Large | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113683126 - ManaEZ Night Splint, Plantar Fasciitis, Small | 2025-10-06 Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight A |
| 00810113683133 - ManaEZ Night Splint, Plantar Fasciitis, Medium | 2025-10-06 Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight A |