Synthes EL-DTY BME Elite Y-Series Drilling Template Kit, NEW, IN-DATE

Synthes EL-DTY BME Elite Y-Series Drilling Template Kit, NEW, IN-DATE
$300 (USD)
Available quantity:1
Description
The Synthes BME Elite Y-Series Drilling Template Kit is a disposable orthopaedic surgical instrument kit intended for use in orthopaedic surgical procedures.
Condition: New
Expiration: 2028-09-01
Included Items: One Drill Template Kit
Quantity Included: 1 Per Box Specifications: - Manufacturer: Synthes GmbH - Model / Version No.: EL-DTY - Catalog Number: ELDTY - Brand: Elite - Orthopaedic surgical procedure kit, non-medicated, single-use - Product Code: KDD – Kit, Surgical Instrument, Disposable - Expiration Date: 2028-09-01 - Lot / Batch Number: Yes - Rx Only: Yes - Combination Product: No - Contains Pharmaceuticals: No - Contains HCT/P: No - Natural Rubber Latex: Not labeled as NRL - MRI Safety: Labeling does not contain MRI Safety Information The Synthes BME Elite Y-Series Drilling Template Kit (model EL-DTY) is classified as a Class I disposable surgical instrument kit under FDA regulation 21 CFR 878.4800. It is designed to support orthopaedic surgical procedures and is not dedicated to orthopaedic implantation. This product carries an active GMDN designation (code 44052) for non-medicated, single-use orthopaedic surgical procedure kits. It is sold as a single unit per base package, includes lot/batch number traceability, and carries an expiration date of September 2028. Features: - Designed for use in orthopaedic surgical procedures - Y-Series drilling template configuration - Single-use, disposable construction - Does not contain pharmaceuticals or HCT/P components Applications: - Orthopaedic surgical procedures requiring drilling template guidance - BME Elite Y-Series surgical workflows WARRANTY/RETURNS: -No warranty is expressed or implied with the sale of this item(s). -No returns on disposables, surgical implants or disposables. "The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."
Specifications
| Manufacturer | Synthes |
| Model | EL-DTY |
| Condition | New |
| Stock Number | DIS-00698 |
| GMDN Code | 44052 |
| GMDN Term | Orthopaedic surgical procedure kit, non-medicated, single-use |
| Product Code | KDD – Kit, Surgical Instrument, Disposable |
| Device Class | 1 |
| Regulation Number | 878.4800 |
| UDI (Primary) | 00810633021972 (GS1) |
| Expiration Date | 2028-09-01 |
| Lot / Batch Number | Yes |
| Rx Only | Yes |
| Combination Product | No |
| Contains Pharmaceuticals | No |
| Contains HCT/P | No |
| Natural Rubber Latex | Not labeled as NRL |
| MRI Safety | Labeling does not contain MRI Safety Information |



