Distal Humerus Plates
- Primary DI
- 00842188115035
- Brand
- Distal Humerus Plates
- Company
- Trimed, INC.
- Model
- HSMNPL-3
- Catalog number
- HSMNPL-3
- Device description
- HumeralSupracondylarMedialNailPlt, Lt, 3-Hole
- Published
- 2017-05-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
trimedortho.comProduct Codes#
| Code | Name |
|---|---|
| HRS | Plate, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K151735 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00842188115035 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00842188115035 | 00842188115035 | 842188115035 | 0842188115035 |
GMDN Terms#
| Term | Definition |
|---|---|
| Arthrodesis nail, non-sterile | A non-sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device intended to be sterilized prior to use. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(661)255-7406 | info@trimedortho.com |
Regulatory Flags#
- DUNS number
- 138041277
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00842188132452 | Tools - TWF | NSF-CADDY-LID | NSF-CADDY-LID | 2026-08-18 |
| 00842188127014 | Tools - FMS | FMS-TRAY-LID | FMS-TRAY-LID | 2023-04-19 |
| 00842188100437 | Foot Plates | SP20-3S | SP20-3S | 2016-09-07 |
| 00842188100444 | Foot Plates | SP20-3M | SP20-3M | 2016-09-07 |
| 00842188100451 | Foot Plates | SP20-4 | SP20-4 | 2016-09-07 |
| 00842188100468 | Foot Plates | SP20-6 | SP20-6 | 2016-09-07 |
| 00842188100475 | Foot Plates | TP20-5 | TP20-5 | 2016-09-07 |
| 00842188100482 | Foot Plates | TP20-7 | TP20-7 | 2016-09-07 |
| 00842188100888 | Locking Plates | BRGP | BRGP | 2016-09-07 |
| 00842188100949 | Hook Plates | MHOOK-5 | MHOOK-5 | 2016-09-07 |
| 00842188100956 | Hook Plates | MHOOK-7 | MHOOK-7 | 2016-09-07 |
| 00842188101526 | Osteotomy Compression Plates | UOCP | UOCP | 2016-09-07 |
| 00842188101533 | Osteotomy Compression Plates | UOCP-S | UOCP-S | 2016-09-07 |
| 00842188105425 | FPS Locking Screw 2.0mm | CLS2.0-06 | CLS2.0-06 | 2016-09-07 |
| 00842188105432 | FPS Locking Screw 2.0mm | CLS2.0-08 | CLS2.0-08 | 2016-09-07 |
| 00842188105449 | FPS Locking Screw 2.0mm | CLS2.0-10 | CLS2.0-10 | 2016-09-07 |
| 00842188105456 | FPS Locking Screw 2.0mm | CLS2.0-12 | CLS2.0-12 | 2016-09-07 |
| 00842188105463 | FPS Locking Screw 2.0mm | CLS2.0-14 | CLS2.0-14 | 2016-09-07 |
| 00842188105470 | FPS Locking Screw 2.0mm | CLS2.0-16 | CLS2.0-16 | 2016-09-07 |
| 00842188105487 | FPS Locking Screw 2.0mm | CLS2.0-18 | CLS2.0-18 | 2016-09-07 |
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