Henry Schein
Kit Shoulder Arthroscopy F/ Emerge Ortho Brunswick Surgery Center
1manufacturer
55catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2023-07-30 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5702784 | 5 | In distribution | |
| 5702806 | 5 | In distribution | |
| 5703065 | 6 | In distribution | |
| 5702780 | 10 | In distribution | |
| 5702906 | 2 | In distribution | |
| 5702949 | 2 | In distribution | |
| 5703153 | 2 | In distribution | |
| 5701590 | In distribution | ||
| 5703266 | 2 | In distribution | |
| 5703153 | 3 | In distribution | |
| 5701606 | In distribution | ||
| 5703094 | 5 | In distribution | |
| 5702186 | 3 | In distribution | |
| 5703200 | 5 | In distribution | |
| 5703137 | 4 | In distribution | |
| 5703065 | 10 | In distribution | |
| 5702896 | 4 | In distribution | |
| 5702897 | 3 | In distribution | |
| 5702946 | 3 | In distribution | |
| 5703235 | 4 | In distribution | |
| 5703137 | 4 | In distribution | |
| 5702945 | 2 | In distribution | |
| 5703135 | 3 | In distribution | |
| 5702907 | 5 | In distribution | |
| 5701589 | In distribution | ||
| 5703235 | 2 | In distribution | |
| 5702945 | 3 | In distribution | |
| 5702946 | 2 | In distribution | |
| 5703158 | 4 | In distribution | |
| 5702947 | 3 | In distribution | |
| 5702948 | 2 | In distribution | |
| 5701583 | In distribution | ||
| 5703152 | 4 | In distribution | |
| 5703200 | 10 | In distribution | |
| 5701652 | In distribution | ||
| 5702783 | 16 | In distribution | |
| 5703205 | 6 | In distribution | |
| 5702808 | 5 | In distribution | |
| 5702809 | 5 | In distribution | |
| 5702905 | 4 | In distribution | |
| 5702807 | 5 | In distribution | |
| 5702805 | 5 | In distribution | |
| 5703135 | 4 | In distribution | |
| 5702947 | 2 | In distribution | |
| 5702182 | 5 | In distribution | |
| 5702804 | 6 | In distribution | |
| 5702948 | 2 | In distribution | |
| 5702949 | 2 | In distribution | |
| 5702781 | 6 | In distribution | |
| 5702962 | 4 | In distribution | |
| 5703066 | 10 | In distribution | |
| 5703158 | 20 | In distribution | |
| 5701574 | In distribution | ||
| 5702913 | 10 | In distribution | |
| 5702908 | 2 | In distribution |
Same Product Code
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|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
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| ACS | American Contract Systems, Inc. | 3,812 |
| Halyard | Avid Medical, Inc. | 1,313 |
| Aligned Medical Solutions | Aligned Medical Solutions | 1,272 |
| Regard™ | ROi CPS LLC | 464 |
| Overwatch | Spinal Elements, Inc. | 223 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 191 |
| Lucent L | Spinal Elements, Inc. | 95 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 87 |
| Integra® | Ascension Orthopedics, Inc. | 81 |
Showing 12 of 367. All products under Orthopedic Tray
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 |
|---|---|---|---|---|---|---|
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 144 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.