# Codman® 245431 > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Integra LifeSciences Production Corporation](https://devicerts.com/manufacturers/integra-lifesciences-production-corporation) (United States) - Name in the registry: CODMAN® 245431 - Device class: Class II (US FDA) - FDA product code: HBA - GMDN: Neurosurgical sponge (13702) ## Registrations and authorizations - **GUDID** · FDA 510(k) · United States · K193346 · decision 2020-11-20 · decision SESE · status: Active · from GUDID - **GUDID** · GUDID listing · United States · UDI-DI 10381780513469 · listed 2020-04-01 · status: Listed (GUDID: in commercial distribution) ## Recalls - Z-0256-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0255-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0237-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0252-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0238-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0241-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0251-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0253-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0254-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0243-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0240-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0250-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0236-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0244-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0242-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0239-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0245-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0249-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0248-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0235-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0247-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0246-2025 · Class II · ongoing · initiated 2024-09-20: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods - Z-0909-2023 · Class II · ongoing · initiated 2022-12-02: Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever. ## Identity - Trade name: CODMAN® [FDA GUDID (AccessGUDID)] - Generic name: Neurosurgical sponge [FDA GUDID (AccessGUDID)] - Model / Ref / Catalog: 245431 [FDA GUDID (AccessGUDID)]; 24-5431 [FDA GUDID (AccessGUDID)] ## Identifiers - Primary DI / UDI-DI: 10381780513469 [FDA GUDID (AccessGUDID)] - 510(k) Number: K193346 [FDA GUDID (AccessGUDID)] - FDA product code: HBA [FDA GUDID (AccessGUDID)] - GMDN term: Neurosurgical sponge (13702) [FDA GUDID (AccessGUDID)] ## Classification - Device class: Class II [FDA GUDID (AccessGUDID)] - Regulation number: 882.4700 [FDA GUDID (AccessGUDID)] - GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)] ## Clinical & Handling - Sterilisation method: Ethylene Oxide [FDA GUDID (AccessGUDID)] ## Properties - Sterilise before use: Yes [FDA GUDID (AccessGUDID)] - Single use: Yes [FDA GUDID (AccessGUDID)] - Prescription use: Yes [FDA GUDID (AccessGUDID)] - Lot / batch number: Yes [FDA GUDID (AccessGUDID)] - Manufacturing date: Yes [FDA GUDID (AccessGUDID)] - Supplied sterile: 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)] ## Source and citation - Cite as: Codman® 245431, Integra LifeSciences Production Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/codman-r-24-5431 (data as of 2026-11-14). - 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: 2026-11-14 - 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/codman-r-24-5431 - 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.