Codman
CODMAN Bulk Surgical Patties X-Ray Detectable 1/2 Inch x 1 1/2 Inches (1.27cm x 3.81cm)
2manufacturers in China registered for this device type
41catalogue numbers in this listing
3recalls on this code
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 | Cerenovus, Inc., United States |
|---|---|
| FDA product code | HBA |
| Device type | Neurosurgical Paddie |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4700 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K880402 |
| Record published | 2016-06-30 |
| Record revised | 2023-09-15 (version 6) |
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 |
| Distribution end date | 2022-09-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 80-1457 | 200 | Withdrawn | |
| 24-5408 | 1,000 | Withdrawn | |
| 24-5437 | 1,000 | Withdrawn | |
| 80-1400 | 200 | Withdrawn | |
| 80-1407 | 200 | Withdrawn | |
| 24-5406 | 1,000 | Withdrawn | |
| 24-5410 | 1,000 | Withdrawn | |
| 24-5433 | 1,000 | Withdrawn | |
| 24-5404 | 1,000 | Withdrawn | |
| 80-1454 | 200 | Withdrawn | |
| 80-1456 | 200 | Withdrawn | |
| 80-1406 | 200 | Withdrawn | |
| 24-5413 | 1,000 | Withdrawn | |
| 80-1450 | 200 | Withdrawn | |
| 80-1452 | 200 | Withdrawn | |
| 24-5435 | 1,000 | Withdrawn | |
| 24-5403 | 1,000 | Withdrawn | |
| 80-1408 | 200 | Withdrawn | |
| 80-1409 | 200 | Withdrawn | |
| 80-1402 | 200 | Withdrawn | |
| 80-1455 | 200 | Withdrawn | |
| 24-5405 | 1,000 | Withdrawn | |
| 24-5431 | 1,000 | Withdrawn | |
| 24-5436 | 1,000 | Withdrawn | |
| 24-5438 | 1,000 | Withdrawn | |
| 80-1401 | 200 | Withdrawn | |
| 80-1449 | 200 | Withdrawn | |
| 80-1399 | 200 | Withdrawn | |
| 24-5434 | 1,000 | Withdrawn | |
| 24-5411 | 1,000 | Withdrawn | |
| 80-1453 | 200 | Withdrawn | |
| 80-1398 | 200 | Withdrawn | |
| 24-5432 | 1,000 | Withdrawn | |
| 80-1451 | 200 | Withdrawn | |
| 80-1403 | 200 | Withdrawn | |
| 24-5402 | 1,000 | Withdrawn | |
| 24-5412 | 1,000 | Withdrawn | |
| 24-5407 | 1,000 | Withdrawn | |
| 80-1404 | 200 | Withdrawn | |
| 80-1397 | 200 | Withdrawn | |
| 80-1396 | 200 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OMT LLC | OMT, LLC | 126 |
| Neuray ® | Medtronic Xomed, Inc. | 63 |
| Codman® | Integra LifeSciences Production Corporation | 42 |
| 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
22 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | UDI-DI | 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 | |
| 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.