{ "format": "devicerts.device.v1", "cite_as": "Pro-000-311, Summit Medical, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/na-pro-000-311 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/na-pro-000-311", "json_url": "https://devicerts.com/devices/na-pro-000-311.json", "markdown_url": "https://devicerts.com/devices/na-pro-000-311.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-11-07", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "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/na-pro-000-311", "disclaimer": "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." }, "device": { "name": "Pro-000-311", "registry_name": "PRO-000-311", "url": "https://devicerts.com/devices/na-pro-000-311", "manufacturer": { "name": "Summit Medical, LLC", "url": "https://devicerts.com/manufacturers/summit-medical-llc", "country": "United States", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class IIb", "system": "EU MDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00385640027120", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00385640027120", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K830228", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "ETD" ], "emdn": [ { "code": "Q03040199", "term": "EAR DRAINAGE AND VENTILATION DEVICES - OTHER" } ], "gmdn": [ { "code": "33794", "term": "Tympanostomy tube" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDD", "number": "B-00385640027120", "number_label": "Basic UDI-DI", "device_udi_di": "00385640027120", "date": "2026-11-06", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00385640027120", "number_label": "UDI-DI", "device_udi_di": null, "date": "2017-02-15", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K830228", "number_label": null, "device_udi_di": null, "date": "1983-03-07", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-1731-2014", "classification": "Class II", "status": "terminated", "initiated": "2014-05-12", "reason": "One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.", "applies": "this device", "via": "K830228" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "SHEPARD WITH WIRE, 1.14mm Lumen, Fluoroplastic", "registries": [ "EUDAMED" ] } ] }, { "label": "Generic name", "values": [ { "value": "Tympanostomy tube", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Device name", "values": [ { "value": "Otological Ventilation Tubes", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / reference", "values": [ { "value": "PRO-000-311", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00385640027120", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00385640027120", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K830228", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "ETD", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Q03040199", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Tympanostomy tube", "code": "33794", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IIb", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "874.3880", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Germany", "registries": [ "EUDAMED" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Clinical & Handling", "fields": [ { "label": "MRI safety", "values": [ { "value": "MR Conditional", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Supplied sterile", "values": [ { "value": "Yes", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "Yes", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Prescription use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }