| Primary Device ID | 00810113682921 |
| NIH Device Record Key | 87ead1bc-5bc3-4fec-a0eb-4b6d02fd9a59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManaEZ Ankle 06 Large |
| Version Model Number | EZANKLE06L |
| Catalog Number | EZANKLE06L |
| 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 | 00810113682921 [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 |
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