Medline
SPONGE,NEURO,0.25"X1.5",XR,STRL,LF,10/PK
2manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | HBA |
| Device type | Neurosurgical Paddie |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4700 |
| Record published | 2022-12-01 |
| Record revised | 2025-04-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: NA |
| Packaging | Case of 20, mc of 240, box of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NEUROSPNG11 | 10 | In distribution | |
| SURGSTRP306 | 10 | In distribution | |
| NEUROSPNG07 | 10 | In distribution | |
| NEUROSPNG03 | 10 | In distribution | |
| NEUROSPNG06 | 10 | In distribution | |
| NEUROSPNG14 | 10 | In distribution | |
| SURGSTRP126 | 10 | In distribution | |
| SURGSTRP106 | 10 | In distribution | |
| SURGSTRP356 | 10 | In distribution | |
| NEUROSPNG15 | 10 | In distribution | |
| NEUROSPNG08 | 10 | In distribution | |
| NEUROSPNG04 | 10 | In distribution | |
| SURGSTRP206 | 10 | In distribution | |
| NEUROSPNG09 | 10 | In distribution | |
| SURGSTRP346 | 10 | In distribution | |
| NEUROSPNG13 | 10 | In distribution | |
| NEUROSPNG02 | 10 | In distribution | |
| NEUROSPNG05 | 10 | In distribution | |
| SURGSTRP146 | 10 | In distribution |
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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140369 | 2014-09-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 4225160 units |
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.