Phantom Hindfoot TTC/TC Nail System
- Primary DI
- 00889795097897
- Brand
- Phantom Hindfoot TTC/TC Nail System
- Company
- PARAGON 28, INC.
- Model
- P31-951-0103
- Catalog number
- P31-951-0103
- Device description
- PRECISION® Guide Alignment Fin
- Published
- 2020-12-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00889795097897 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00889795097897 | 00889795097897 | 889795097897 | 0889795097897 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic fixation implant alignment tool | A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 042961576
- 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
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00889795153845 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-1 | P50-900-BGSL-1 | 2026-02-19 |
| 00889795153852 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-2 | P50-900-BGSL-2 | 2026-02-19 |
| 00889795153883 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-3 | P50-900-BGSL-3 | 2026-02-19 |
| 00889795153890 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-4 | P50-900-BGSL-4 | 2026-02-19 |
| 00889795153906 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-1 | P50-900-SBSL-1 | 2026-02-19 |
| 00889795153913 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-2 | P50-900-SBSL-2 | 2026-02-19 |
| 00889795153944 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-3 | P50-900-SBSL-3 | 2026-02-19 |
| 00889795153951 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-4 | P50-900-SBSL-4 | 2026-02-19 |
| 00889795153968 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-5 | P50-900-SBSL-5 | 2026-02-19 |
| 00889795153975 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-6 | P50-900-SBSL-6 | 2026-02-19 |
| 00889795153982 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-7 | P50-900-SBSL-7 | 2026-02-19 |
| 00889795153999 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-5 | P50-900-BGSL-5 | 2026-02-19 |
| 00889795154002 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-6 | P50-900-BGSL-6 | 2026-02-19 |
| 00889795154019 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-7 | P50-900-BGSL-7 | 2026-02-19 |
| 00889795154026 | APEX 3D Total Ankle Replacement System | P10-844-FTPP | P10-844-FTPP | 2026-02-19 |
| 00889795153661 | Precision MIS Bunion System | P27-200-1000 | P27-200-1000 | 2026-02-06 |
| 00889795128737 | Baby Gorilla/Gorilla Plating System | P99-151-P51L-S | P99-151-P51L-S | 2026-01-29 |
| 00889795110879 | APEX 3D Total Ankle Replacement System | P99-151-P105-1-S | P99-151-P105-1-S | 2026-01-28 |
| 00889795118400 | APEX 3D Total Ankle Replacement System | P99-152-P104-S | P99-152-P104-S | 2026-01-28 |
| 00889795118417 | APEX 3D Total Ankle Replacement System | P99-152-P105-S | P99-152-P105-S | 2026-01-28 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00198506090998 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091001 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091018 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091025 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091032 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091049 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091056 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091063 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091070 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091087 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00841523181360 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181681 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181698 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181704 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181711 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181728 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181735 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181742 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181759 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181766 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181773 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181780 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181797 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181803 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181810 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181827 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181834 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181841 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181858 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181865 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |