Codman®
CODMAN® Bulk Surgical Patties X-Ray Detectable 1/2" x 1 1/2" (1.27cm x 3.81cm)
2manufacturers in China registered for this device type
42catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HBA |
| Device type | Neurosurgical Paddie |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4700 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K880402 |
| Record published | 2020-04-01 |
| Record revised | 2025-06-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 0.79 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 801457 | 89mm x 152mm | 200 | In distribution |
| 801400 | 1.27cm x 1.27cm | 200 | In distribution |
| 801401 | 3/4 Inch x 3/4 Inch | 200 | In distribution |
| 801454 | 1 1/2 Inch x 6 Inch | 200 | In distribution |
| 801453 | 1 Inch x 6 Inch | 200 | In distribution |
| 245413 | 3 Inch x 3 Inch | 1,000 | In distribution |
| 801456 | 3 Inch x 6 Inch | 200 | In distribution |
| 245438 | 3 1/2 Inch x 6 Inch | 1,000 | In distribution |
| 801455 | 51mm x 152mm | 200 | In distribution |
| 245406 | 1/2 Inch x 1 Inch | 1,000 | In distribution |
| 801399 | 1/4 Inch x 1/4 Inch | 200 | In distribution |
| 801449 | 1/8 Inch x 6 Inch | 200 | In distribution |
| 245404 | 1.27cm x 1.27cm | 1,000 | In distribution |
| 801460 | 10 | In distribution | |
| 801406 | 1/2 Inch x 2 Inch | 200 | In distribution |
| 801451 | 13mm x 152mm | 200 | In distribution |
| 801404 | 1/2 Inch x 1 1/2 Inch | 200 | In distribution |
| 801402 | 1.27cm x 2.54cm | 200 | In distribution |
| 245435 | 38mm x 152mm | 1,000 | In distribution |
| 801408 | 1 Inch x 3 Inch | 200 | In distribution |
| 801450 | 1/4 Inch x 6 Inch | 200 | In distribution |
| 245412 | 2.54cm x 7.62cm | 1,000 | In distribution |
| 245411 | 1 Inch x 3 Inch | 1,000 | In distribution |
| 245431 | 6mm x 152mm | 1,000 | In distribution |
| 801407 | 1.27cm x 7.62cm | 200 | In distribution |
| 801409 | 3 Inch x 3 Inch | 200 | In distribution |
| 245407 | 2.54cm x 2.54cm | 1,000 | In distribution |
| 245408 | 1/2 Inch x 1 1/2 Inch | 1,000 | In distribution |
| 801452 | 3/4 Inch x 6 Inch | 200 | In distribution |
| 245402 | 6mm x 76mm | 1,000 | In distribution |
| 801397 | 0.64cm x 3.81cm | 200 | In distribution |
| 801403 | 2.54cm x 2.54cm | 200 | In distribution |
| 801398 | 0.64cm x 7.62cm | 200 | In distribution |
| 245434 | 1 Inch x 6 Inch | 1,000 | In distribution |
| 245410 | 1/2 Inch x 2 Inch | 1,000 | In distribution |
| 245437 | 76mm x 152mm | 1,000 | In distribution |
| 245405 | 1.91cm x 1.91cm | 1,000 | In distribution |
| 245403 | 6mm x 6mm | 1,000 | In distribution |
| 245432 | 13mm x 152mm | 1,000 | In distribution |
| 245433 | 3/4 Inch x 6 Inch | 1,000 | In distribution |
| 801396 | Outer Diameter 0.79 cm | 200 | In distribution |
| 245436 | 51mm x 152mm | 1,000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OMT LLC | OMT, LLC | 126 |
| Neuray ® | Medtronic Xomed, Inc. | 63 |
| Codman | Cerenovus, Inc. | 41 |
| Americot | American Surgical Company, LLC | 39 |
| Spetzler Neuro Patties | OMT, LLC | 35 |
| Merocel | Medtronic Xomed, Inc. | 34 |
| Ray-Cot | American Surgical Company, LLC | 26 |
| Uniqcot | American Surgical Company, LLC | 24 |
| Medline | Medline Industries, Inc. | 19 |
| Zevo™ Anterior Cervical Plate System | Medtronic Sofamor Danek, Inc. | 17 |
| Ultracot | American Surgical Company, LLC | 15 |
| Telfa | American Surgical Company, LLC | 13 |
Showing 12 of 24. All products under Neurosurgical Paddie
Recalls Naming This Product
26 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 1791 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 2615 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 2894 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 21553 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 168803 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 33478 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 80515 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 44231 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 69179 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 56082 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 201914 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 93782 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 9563 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 826 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 6706 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | ||
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 4818 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 10719 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 2056 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 1222 | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 1454 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | 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 | 3494 units | |
| Integra Lifesciences Corporation | 510(k) number | 2022-12-02 | Class II | Process control | 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. | 168 US; 3 OUS | |
| Cerenovus, Inc. | 510(k) number | 2010-07-16 | Not classified | Process control | Surgical Pattie x-ray stripe (radio-opaque marker) became detached | 673 boxes (20 pouches of 10 patties per box) | 2012-07-09 |
| Cerenovus, Inc. | 510(k) number | 2010-07-16 | Not classified | Process control | Surgical Pattie x-ray stripe (radio-opaque marker) became detached | 4407 boxes (20 pouches of 10 patties) | 2012-07-09 |
| Cerenovus, Inc. | 510(k) number | 2010-07-16 | Not classified | Process control | Surgical Pattie x-ray stripe (radio-opaque marker) may become detached | 229 boxes (100 cards/10 patties each card) | 2012-07-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.