Medline
Drill KIT, 2.9MM Push Anchor
1manufacturer
54catalogue 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 | Medline Industries, 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 | 2021-08-18 |
| Record revised | 2022-06-17 (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 |
| Storage | Special storage condition: Protect from freezing, Avoid excessive heat |
| Packaging | Case of 2 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ46534J | In distribution | |
| CDS981505K | In distribution | |
| CDS940841X | In distribution | |
| CDS780112I | In distribution | |
| CDS940842X | In distribution | |
| CDS982335O | In distribution | |
| CDS983203I | In distribution | |
| CDS983194I | In distribution | |
| CDS983414D | In distribution | |
| MDKT0029 | In distribution | |
| CDS941186S | In distribution | |
| CDS941190G | In distribution | |
| DYNJ42438C | In distribution | |
| CDS941187T | In distribution | |
| CDS983031P | In distribution | |
| CDS982341Q | In distribution | |
| CDS981786O | In distribution | |
| CDS981510I | In distribution | |
| CDS982601I | In distribution | |
| CDS941313X | In distribution | |
| CDS982338P | In distribution | |
| CDS940047AB | In distribution | |
| CDS982390M | In distribution | |
| CDS941189J | In distribution | |
| CDS780111N | In distribution | |
| CDS940843X | In distribution | |
| CDS941167L | In distribution | |
| CDS940857I | In distribution | |
| DYNJ0100999G | In distribution | |
| CDS940859K | In distribution | |
| CDS940844V | In distribution | |
| CDS940048AC | In distribution | |
| CDS982198I | In distribution | |
| CDS981786N | In distribution | |
| DYKS1176A | In distribution | |
| MDKT0033 | In distribution | |
| DYNJ42963F | In distribution | |
| DYNJ36273G | In distribution | |
| CDS983029U | In distribution | |
| CDS982383K | In distribution | |
| CDS983189F | In distribution | |
| CDS982684P | In distribution | |
| CDS983251U | In distribution | |
| DYNJ39475D | In distribution | |
| CDS984664G | In distribution | |
| CDS780204Q | In distribution | |
| DYNJ0101282D | In distribution | |
| CDS982685P | In distribution | |
| CDS983031O | In distribution | |
| DYNJ44001C | In distribution | |
| DYNJ46552J | In distribution | |
| CDS983030S | In distribution | |
| CDS983415D | In distribution | |
| DYNJ0373136L | In distribution |
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 |
| 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
6 recalls name this product by its own identifiers, 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. | 1552486 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 117907 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 160980 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-11 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. | 14589 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 252162 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 101,102 cases (227,538 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.