NA
- Primary DI
- 00763000140250
- Brand
- NA
- Company
- MEDTRONIC SOFAMOR DANEK, INC.
- Model
- 5580164
- Device description
- TEMPLATE 5580164 ROD CURVE 5.5/6.0
- Published
- 2022-05-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HTW | Bit, Drill | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00763000140250 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00763000140250 | 00763000140250 | 763000140250 | 0763000140250 |
GMDN Terms
| Term | Definition |
|---|
| Surgical implant template, reusable | A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 830350380
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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| 00810168190457 | NA | PACIFIC INSTRUMENTS, INC. | HTW | 2026-05-26 |
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| 04048844358792 | MUTARS® | implantcast GmbH | HTW | 2026-03-24 |
| 04048844358839 | MUTARS® | implantcast GmbH | HTW | 2026-03-24 |
| 00840314270245 | gSource | GSOURCE LLC | HTW | 2026-03-20 |
| 00840314270252 | gSource | GSOURCE LLC | HTW | 2026-03-20 |
| 00840314270269 | gSource | GSOURCE LLC | HTW | 2026-03-20 |
| 00763000884543 | n/a | MEDTRONIC SOFAMOR DANEK, INC. | HTW | 2026-03-13 |
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| 06974940307038 | endophix | Suzhou Endophix Co., Ltd. | HTW | 2026-03-03 |
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| 04026575282883 | General Instrument | WALDEMAR LINK GmbH & Co. KG | HTW | 2026-02-02 |
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| 04026575414932 | General Instrument | WALDEMAR LINK GmbH & Co. KG | HTW | 2026-02-02 |
| 04026575427130 | General Instrument | WALDEMAR LINK GmbH & Co. KG | HTW | 2026-02-02 |
| 00810056993122 | corra | Carlsmed, Inc. | HTW | 2026-01-30 |
| 00810056993153 | corra | Carlsmed, Inc. | HTW | 2026-01-30 |
| 00810056993160 | corra | Carlsmed, Inc. | HTW | 2026-01-30 |
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