# EXOGEN Metatarsal Strap 71034660

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/exogen-metatarsal-strap-71034660>
- Manufacturer: [Bioventus LLC](https://devicerts.com/manufacturers/bioventus-llc) (United States)
- Device class: Class II (US FDA)
- FDA product code: LOF
- GMDN: Personal device holder, single-use (31072)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI M937710346601 · listed 2021-12-17 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA PMA · United States · P900009 · decision 1994-10-05 · decision APRL · status: Active · from GUDID

## Recalls

- Z-0810-2021 · Class II · terminated · initiated 2020-12-17: Product may contain white particulates that are microbial in nature.
- Z-1695-2009 ·  · terminated · initiated 2009-06-05 · matched through shared submission P900009, may concern other models: Problems with transducer may result in a reduced ultrasound output.
- Z-1696-2009 ·  · terminated · initiated 2009-06-05 · matched through shared submission P900009, may concern other models: Problems with transducer may result in a reduced ultrasound output.

## Identity

- Trade name: EXOGEN Metatarsal Strap [FDA GUDID (AccessGUDID)]
- Generic name: Personal device holder, single-use [FDA GUDID (AccessGUDID)]
- Model / reference: 71034660 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: M937710346601 [FDA GUDID (AccessGUDID)]
- PMA number: P900009 [FDA GUDID (AccessGUDID)]
- FDA product code: LOF [FDA GUDID (AccessGUDID)]
- GMDN term: Personal device holder, single-use (31072) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 890.5870 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: EXOGEN Metatarsal Strap 71034660, Bioventus LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/exogen-metatarsal-strap-71034660 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/exogen-metatarsal-strap-71034660.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/exogen-metatarsal-strap-71034660
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.