Aligned Medical Solutions
Tetro Shoulder Arthroscopy Pack
1manufacturer
1,272catalogue 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 | Aligned Medical Solutions |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2018-11-14 |
| Record revised | 2023-07-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 3, case of 6, case of 5, case of 4, case of 2, case of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMS7870A | In distribution | |
| AMS10994A | In distribution | |
| AMS13430B | In distribution | |
| AMS14710 | In distribution | |
| AMS15520 | In distribution | |
| AMS17213 | In distribution | |
| AMS15047 | In distribution | |
| PSS3422E | In distribution | |
| AMS2190 | In distribution | |
| AMS13852C | In distribution | |
| AMS15614 | In distribution | |
| AMS10062 | In distribution | |
| AMS10877A | In distribution | |
| WAL1218 | In distribution | |
| AMS4020D | In distribution | |
| AMS13146B | In distribution | |
| AMS9240A | In distribution | |
| AMS14115 | In distribution | |
| AMS4024B | In distribution | |
| AMS15778 | In distribution | |
| AMS12058A | In distribution | |
| CPA341213 | In distribution | |
| CMP1078E | In distribution | |
| AMS6603B | In distribution | |
| AMS3236A | In distribution | |
| AMS7454B | In distribution | |
| AMS2408B | In distribution | |
| AMS10640 | In distribution | |
| AMS12358B | In distribution | |
| AMS11765 | In distribution | |
| AMS9509C | In distribution | |
| AMS3152E | In distribution | |
| AMS5380J | In distribution | |
| AMS7810 | In distribution | |
| AMS5440C | In distribution | |
| AMS3551C | In distribution | |
| AMS7712 | In distribution | |
| AMS13959B | In distribution | |
| AMS17525 | In distribution | |
| AMS15191 | In distribution | |
| AMS13103 | In distribution | |
| AMS7249 | In distribution | |
| AMS13430C | In distribution | |
| 0029443 | In distribution | |
| AMS8397 | In distribution | |
| AMS17108 | In distribution | |
| AMS17709 | In distribution | |
| AMS14389A | In distribution | |
| AMS10873 | In distribution | |
| AMS3154B | In distribution | |
| AMS5395A | In distribution | |
| AMS12338B | In distribution | |
| AMS13956B | In distribution | |
| AMS7755B | In distribution | |
| AMS7616E | In distribution | |
| AMS6498 | In distribution | |
| AMS17868 | In distribution | |
| AMS10560 | In distribution | |
| AMS3150C | In distribution | |
| AMS11969C | In distribution | |
| AMS6458A | In distribution | |
| AMS8898 | In distribution | |
| AMS17569 | In distribution | |
| AMS9666A | In distribution | |
| AMS12837 | In distribution | |
| AMS13959C | In distribution | |
| AMS10950 | In distribution | |
| AMS11841 | In distribution | |
| AMS7622A | In distribution | |
| AMS10609A | In distribution | |
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| AMS17108B | In distribution | |
| AMS8622A | In distribution | |
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| AMS9935B | In distribution | |
| AMS6160A | In distribution | |
| AMS13519 | In distribution | |
| AMS7372A | In distribution | |
| AMS9303 | In distribution | |
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| AMS5903C | In distribution | |
| PSS2691B | In distribution | |
| AMS8263 | In distribution | |
| AMS17570 | In distribution | |
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| AMS7452 | In distribution | |
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| AMS14137 | In distribution | |
| CH1003B | In distribution | |
| AMS13369 | In distribution | |
| AMS13585B | In distribution | |
| AMS4596B | In distribution | |
| AMS10094A | In distribution | |
| AMS5918 | In distribution | |
| AMS4021 | In distribution | |
| AMS7066E | In distribution | |
| AMS7133A | In distribution | |
| AMS5240A | In distribution | |
| AMS9495E | In distribution | |
| PSS1842A | In distribution | |
| AMS10094B | In distribution | |
| AMS3154G | In distribution | |
| AMS18876 | In distribution | |
| AMS3151C | In distribution | |
| AMS12019 | In distribution | |
| CH1021 | In distribution | |
| AMS12358C | In distribution | |
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| AMS13958B | In distribution | |
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| AMS13431D | In distribution | |
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| AMS9713B | In distribution | |
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| AMS6583B | In distribution | |
| AMS3155G | In distribution | |
| AMS8626D | In distribution | |
| AMS2762A | In distribution | |
| PSS3466D | In distribution | |
| AMS9209 | In distribution | |
| AMS7871 | In distribution | |
| AMS12837A | In distribution | |
| AMS7067C | In distribution | |
| AMS14389 | In distribution | |
| AMS5183 | In distribution | |
| AMS12610 | In distribution | |
| AMS7660 | In distribution | |
| AMS6472A | In distribution | |
| AMS7452B | In distribution | |
| AMS11766B | In distribution | |
| AMS17654 | In distribution | |
| AMS15855 | In distribution | |
| AMS4067D | In distribution | |
| AMS12521 | In distribution | |
| AMS13851 | In distribution | |
| AMS6160E | In distribution | |
| AMS13850B | In distribution | |
| AMS4764 | In distribution | |
| AMS13748B | In distribution | |
| AMS13748D | In distribution | |
| AMS7757A | In distribution | |
| AMS12810 | In distribution | |
| AMS16124A | In distribution | |
| AMS10815 | In distribution | |
| AMS13429C | In distribution | |
| AMS3783B | In distribution | |
| AMS11923C | In distribution | |
| AMS3153B | In distribution | |
| AMS13387A | In distribution | |
| AMS14387 | In distribution | |
| AMS1372A | In distribution | |
| AMS12606 | In distribution | |
| AMS14933 | In distribution | |
| AMS13586 | In distribution | |
| AMS13958A | In distribution | |
| AMS13162 | In distribution | |
| AMS4960 | In distribution | |
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| AMS7148A | In distribution | |
| AMS16450A | In distribution | |
| AMS15845A | In distribution | |
| AMS14079 | In distribution | |
| AMS12557 | In distribution | |
| AMS12474C | In distribution | |
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| AMS15325A | In distribution | |
| AMS5379H | In distribution | |
| AMS11923B | In distribution | |
| AMS11476 | In distribution | |
| AMS18834 | In distribution | |
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| AMS8125 | In distribution | |
| AMS5344A | In distribution | |
| AMS7875A | In distribution | |
| AMS9649 | In distribution | |
| AMS16804 | In distribution | |
| AMS12380B | In distribution | |
| AMS12521A | In distribution | |
| AMS4671 | In distribution | |
| CH1016 | In distribution | |
| AMS4691 | In distribution | |
| AMS17863 | In distribution | |
| AMS18835 | In distribution | |
| AMS10557B | In distribution | |
| AMS3711B | In distribution | |
| AMS11774A | In distribution | |
| AMS15853 | In distribution | |
| AMS14628 | In distribution | |
| AMS7289 | In distribution | |
| AMS12740 | In distribution | |
| AMS13748A | In distribution | |
| AMS6111A | In distribution | |
| AMS18221 | In distribution | |
| AMS11243 | In distribution | |
| AMS3154F | In distribution | |
| AMS14615 | In distribution | |
| AMS7335 | In distribution | |
| AMS13428C | In distribution | |
| AMS7451A | In distribution | |
| AMS16807 | In distribution | |
| AMS12992 | In distribution | |
| AMS16450B | In distribution | |
| PSS3422C | In distribution | |
| AMS4021I | In distribution | |
| AMS4333C | In distribution | |
| AMS13430A | In distribution | |
| AMS16960 | In distribution | |
| AMS5380I | In distribution | |
| AMS13956A | In distribution | |
| AMS13429A | In distribution | |
| AMS4669A | In distribution | |
| AMS13597A | In distribution | |
| AMS8938 | In distribution | |
| AMS16123A | In distribution | |
| AMS5819B | In distribution | |
| AMS5901A | In distribution | |
| AMS10880A | In distribution | |
| AMS13715A | In distribution | |
| AMS13585 | In distribution | |
| AMS16419 | In distribution | |
| AMS16124 | In distribution | |
| AMS5182 | In distribution | |
| AMS14079B | In distribution | |
| AMS8095 | In distribution | |
| AMS9106B | In distribution | |
| AMS15768A | In distribution | |
| AMS4020C | In distribution | |
| AMS6564B | In distribution | |
| AMS10557C | In distribution | |
| AMS7067G | In distribution | |
| AMS14346A | In distribution | |
| AMS9435 | In distribution | |
| AMS7290A | In distribution | |
| AMS10995A | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
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| ACS | American Contract Systems, Inc. | 3,812 |
| Halyard | Avid Medical, Inc. | 1,313 |
| 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 |
| Sapphire | Spinal Elements, Inc. | 76 |
Showing 12 of 367. All products under Orthopedic Tray
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Windstone Medical Packaging, Inc. | UDI-DI | 2026-06-08 | Class II | Material/Component Contamination | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin le | 7306 units |
| Windstone Medical Packaging, Inc. | UDI-DI | 2023-04-24 | Class II | Unknown/Undetermined by firm | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient | 30 kits |
| Windstone Medical Packaging, Inc. | UDI-DI | 2023-04-24 | Class II | Unknown/Undetermined by firm | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient | 90 kits |
| Windstone Medical Packaging, Inc. | UDI-DI | 2023-04-24 | Class II | Unknown/Undetermined by firm | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient | 60 kits |
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.