Codman Bicol
CODMAN BICOL Collagen Sponge
2manufacturers in China registered for this device type
1catalogue number
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 |
| Premarket notification | Exempt |
| Record published | 2016-06-30 |
| Record revised | 2023-09-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 10 |
| Distribution end date | 2022-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80-1460 | Withdrawn |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 |
| 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 |
Showing 12 of 24. All products under Neurosurgical Paddie
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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.