Lucent L
Lucent® Lateral Inserters AND Trials Tray Bottom Insert
1manufacturer
95catalogue 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 | Spinal Elements, Inc., United States |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-11-25 |
| Record revised | 2023-04-04 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-01-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80005-000-51 | In distribution | |
| 80009-000-05 | In distribution | |
| 80011-000-05 | In distribution | |
| 80009-000-01 | In distribution | |
| P10001-000-62 | In distribution | |
| 80005-000-30 | In distribution | |
| 80011-000 | In distribution | |
| 12200-000-72 | In distribution | |
| P10001-000-20 | In distribution | |
| 80005-000-60 | In distribution | |
| 80009-000-03 | In distribution | |
| 80005-000-71 | In distribution | |
| 11800-000-03 | In distribution | |
| 11800-000-80 | In distribution | |
| 11800-000-82 | In distribution | |
| 80005-000-20 | In distribution | |
| 80002-000-02 | In distribution | |
| 12230-600 | In distribution | |
| 80010-000-04 | In distribution | |
| 80005-000-80 | In distribution | |
| 80002-000-05 | In distribution | |
| 11006-000-03 | In distribution | |
| 11006-000-02 | In distribution | |
| 80006-000-50 | In distribution | |
| 12230-600-02 | In distribution | |
| 80006-000-20 | In distribution | |
| 12230-600-03 | In distribution | |
| P10001-000-90 | In distribution | |
| 80006-000-52 | In distribution | |
| 80005-000-72 | In distribution | |
| 80006-000-10 | In distribution | |
| 80008-000-05 | In distribution | |
| 80003-000-02 | In distribution | |
| 80005-000-62 | In distribution | |
| P10001-000-80 | In distribution | |
| P10001-000-72 | In distribution | |
| 80005-000-82 | In distribution | |
| 80002-000 | In distribution | |
| 80010-000 | In distribution | |
| 80010-000-05 | In distribution | |
| 80008-000-02 | In distribution | |
| P10001-000-52 | In distribution | |
| 80001-000 | In distribution | |
| 80010-000-01 | In distribution | |
| 80010-000-03 | In distribution | |
| 80008-000-01 | In distribution | |
| 11006-000-01 | In distribution | |
| 80005-000-52 | In distribution | |
| 80000-000 | In distribution | |
| P10001-000-82 | In distribution | |
| 80002-000-04 | In distribution | |
| 80005-000-50 | In distribution | |
| 80011-000-03 | In distribution | |
| P10001-000-70 | In distribution | |
| 80006-000 | In distribution | |
| 11006-000-04 | In distribution | |
| 80005-000-61 | In distribution | |
| 80006-000-40 | In distribution | |
| 11800-000-70 | In distribution | |
| 80003-000-01 | In distribution | |
| 80008-000 | In distribution | |
| 80005-000-10 | In distribution | |
| 80008-000-04 | In distribution | |
| 80011-000-01 | In distribution | |
| P10001-000-92 | In distribution | |
| 80003-000-03 | In distribution | |
| 80002-000-01 | In distribution | |
| 80005-000 | In distribution | |
| 80009-000 | In distribution | |
| 80011-000-04 | In distribution | |
| 80002-000-03 | In distribution | |
| 80004-000-01 | In distribution | |
| 80006-000-51 | In distribution | |
| P11000-000-62 | In distribution | |
| 80001-000-01 | In distribution | |
| P11000-000-60 | In distribution | |
| P10001-000-60 | In distribution | |
| 11800-000-72 | In distribution | |
| 80009-000-02 | In distribution | |
| 80005-000-81 | In distribution | |
| 80009-000-04 | In distribution | |
| 80008-000-03 | In distribution | |
| 11800-000 | In distribution | |
| 12200-000-70 | In distribution | |
| 80006-000-30 | In distribution | |
| 11006-000 | In distribution | |
| 11800-000-01 | In distribution | |
| 80004-000-02 | In distribution | |
| 80005-000-70 | In distribution | |
| 11800-000-02 | In distribution | |
| 80004-000 | In distribution | |
| 80003-000 | In distribution | |
| P11000-000-61 | In distribution | |
| P10001-000-50 | In distribution | |
| 80001-000-02 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
| Avid TruCustom | Avid Medical, Inc. | 3,990 |
| 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 |
| 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
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.