Neuray ®
Packing 8004056 Neuray 200PK 76X152MM
2manufacturers in China registered for this device type
63catalogue 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 | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | HBA |
| Device type | Neurosurgical Paddie |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4700 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K923027 |
| Record published | 2017-10-09 |
| Record revised | 2024-06-17 (version 5) |
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 |
| Packaging | Pack of 200 |
| Sizes | Length 7 to 152 mm; width 7 to 152 mm; length 0.25 to 3.5 in; width 0.25 to 6 in |
| Distribution end date | 2021-07-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8004001 | Length 0.75 in | In distribution | |
| 8004009 | Width 3.0 in | In distribution | |
| 8004003 | Length 25.0 mm | In distribution | |
| 8004006 | Length 13.0 mm | In distribution | |
| 8004005 | Length 1.5 in | In distribution | |
| 8004000 | Width 13.0 mm | In distribution | |
| 8004007 | Width 3.0 in | In distribution | |
| 8004004 | Length 0.5 in | In distribution | |
| 8004002 | Length 13.0 mm | In distribution | |
| 8004008 | Width 76.0 mm | In distribution | |
| 8004007 | Length 13.0 mm | Withdrawn | |
| 8004056 | Length 76.0 mm | Withdrawn | |
| 8004056 | Length 76.0 mm | Withdrawn | |
| 8004008 | Length 25.0 mm | Withdrawn | |
| 8004009 | Width 76.0 mm | 200 | Withdrawn |
| 8003097 | Length 38.0 mm | 200 | Withdrawn |
| 8004057 | Length 125.0 mm | 200 | Withdrawn |
| 8004006 | Length 51.0 mm | 200 | Withdrawn |
| 8004050 | Width 152.0 mm | Withdrawn | |
| 8004000 | Length 13.0 mm | Withdrawn | |
| 8004002 | Width 25.0 mm | Withdrawn | |
| 8003098 | Width 76.0 mm | Withdrawn | |
| 8004050 | Width 7.0 mm | 200 | Withdrawn |
| 8004008 | Width 25.0 mm | 200 | Withdrawn |
| 8003099 | Width 7.0 mm | 200 | Withdrawn |
| 8004002 | Width 13.0 mm | 200 | Withdrawn |
| 8004054 | Length 38.0 mm | Withdrawn | |
| 8003099 | Width 7.0 mm | Withdrawn | |
| 8004000 | Length 13.0 mm | 200 | Withdrawn |
| 8004005 | Width 38.0 mm | Withdrawn | |
| 8003098 | Length 0.25 in | Withdrawn | |
| 8004055 | Width 152.0 mm | Withdrawn | |
| 8004050 | Length 0.25 in | Withdrawn | |
| 8004007 | Length 76.0 mm | 200 | Withdrawn |
| 8003097 | Length 7.0 mm | Withdrawn | |
| 8004003 | Width 25.0 mm | 200 | Withdrawn |
| 8004001 | Length 19.0 mm | Withdrawn | |
| 8004055 | Length 152.0 mm | Withdrawn | |
| 8003099 | Width 0.25 in | Withdrawn | |
| 8004003 | Length 25.0 mm | Withdrawn | |
| 8003098 | Length 76.0 mm | 200 | Withdrawn |
| 8003097 | Length 7.0 mm | Withdrawn | |
| 8004053 | Width 25.0 mm | 200 | Withdrawn |
| 8004051 | Length 13.0 mm | Withdrawn | |
| 8004004 | Width 13.0 mm | 200 | Withdrawn |
| 8004004 | Width 38.0 mm | Withdrawn | |
| 8004052 | Width 152.0 mm | Withdrawn | |
| 8004051 | Length 125.0 mm | 200 | Withdrawn |
| 8004053 | Width 6.0 in | Withdrawn | |
| 8004052 | Width 152.0 mm | Withdrawn | |
| 8004056 | Length 125.0 mm | 200 | Withdrawn |
| 8004054 | Length 38.0 mm | Withdrawn | |
| 8004057 | Length 89.0 mm | Withdrawn | |
| 8004054 | Width 38.0 mm | 200 | Withdrawn |
| 8004057 | Length 89.0 mm | Withdrawn | |
| 8004006 | Length 13.0 mm | Withdrawn | |
| 8004051 | Width 152.0 mm | Withdrawn | |
| 8004009 | Length 76.0 mm | Withdrawn | |
| 8004005 | Width 38.0 mm | 200 | Withdrawn |
| 8004055 | Length 2.0 in | Withdrawn | |
| 8004053 | Width 152.0 mm | Withdrawn | |
| 8004001 | Width 19.0 mm | 200 | Withdrawn |
| 8004052 | Width 19.0 mm | 200 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OMT LLC | OMT, LLC | 126 |
| 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 |
| Telfa | American Surgical Company, LLC | 13 |
Showing 12 of 24. All products under Neurosurgical Paddie
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.