Geminus LTN-3HL
GUDID 00841506105482
SKELETAL DYNAMICS L.L.C.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 00841506105482 |
| NIH Device Record Key | f615582b-938e-4fba-93f4-1535c38d12e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Geminus |
| Version Model Number | GEMINUS VDR Plate, Narrow, 3 Hole, Left |
| Catalog Number | LTN-3HL |
| Company DUNS | 869056148 |
| Company Name | SKELETAL DYNAMICS L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841506105482 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111620
FDA Product Code
| HRS | Plate, fixation, bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-21 |
On-Brand Devices [Geminus]
| 00841506109077 | Drill, 2.0mm x 127mm |
| 00841506105703 | Assembled, GEMINUS Volar Distal Radius Plate, Stan |
| 00841506105697 | Assembled, GEMINUS Volar Distal Radius Plate, Stan |
| 00841506105680 | Assembled, GEMINUS Volar Distal Radius Plate, Stan |
| 00841506105673 | Assembled, GEMINUS Volar Distal Radius Plate, Stan |
| 00841506105666 | Assembled, GEMINUS Volar Distal Radius Plate, Stan |
| 00841506105659 | Assembled, GEMINUS Volar Distal Radius Plate, Stan |
| 00841506105642 | GEMINUS VDR Plate, Standard, 7 Hole, Left |
| 00841506105635 | GEMINUS VDR Plate, Standard, 7 Hole, Right |
| 00841506105628 | GEMINUS VDR Plate, Standard, 4 Hole, Left |
| 00841506105611 | GEMINUS VDR Plate, Standard, 4 Hole, Right |
| 00841506105604 | GEMINUS VDR Plate, Narrow, 4 Hole, Left |
| 00841506105598 | GEMINUS VDR Plate, Narrow, 4 Hole, Right |
| 00841506105581 | GEMINUS Volar Distal Radius Plate System - Instrum |
| 00841506105574 | GEMINUS Volar Distal Radius Plate System - Implant |
| 00841506105567 | Pre-Loaded Drill Guide, 2.0mm (Green) |
| 00841506105550 | Pre-Loaded Drill Guide, 2.0mm (Magenta) |
| 00841506105543 | Reusable Compression Screw, 2.7mm |
| 00841506105536 | Pre-Loaded Drill Guide, 2.0mm (Blue) |
| 00841506105529 | GEMINUS VDR Plate, Wide, 4 Hole, Left |
| 00841506105512 | GEMINUS VDR Plate, Wide, 4 Hole, Right |
| 00841506105505 | GEMINUS VDR Plate, Standard, 3 Hole, Left |
| 00841506105499 | GEMINUS VDR Plate, Standard, 3 Hole, Right |
| 00841506105482 | GEMINUS VDR Plate, Narrow, 3 Hole, Left |
| 00841506105475 | GEMINUS VDR Plate, Narrow, 3 Hole, Right |
| 00841506105468 | GEMINUS Select Instrument Tray |
| 00841506105451 | GEMINUS Select Implant Tray |
| 00841506105406 | Handle, AO QC, Fixed |
| 00841506103730 | Washer, Button |
| 00841506103624 | Threaded Peg, Non-Locking, 2.7mm x 32mm, Ti |
| 00841506103617 | Threaded Peg, Non-Locking, 2.7mm x 30mm, Ti |
| 00841506103600 | Threaded Peg, Non-Locking, 2.7mm x 28mm, Ti |
| 00841506103594 | Threaded Peg, Non-Locking, 2.7mm x 26mm, Ti |
| 00841506103587 | Threaded Peg, Non-Locking, 2.7mm x 24mm, Ti |
| 00841506103570 | Threaded Peg, Non-Locking, 2.7mm x 22mm, Ti |
| 00841506103563 | Threaded Peg, Non-Locking, 2.7mm x 20mm, Ti |
| 00841506103556 | Threaded Peg, Non-Locking, 2.7mm x 18mm, Ti |
| 00841506103549 | Threaded Peg, Non-Locking, 2.7mm x 16mm, Ti |
| 00841506103532 | Threaded Peg, Non-Locking, 2.7mm x 14mm, Ti |
| 00841506103525 | Threaded Peg, Non-Locking, 2.7mm x 12mm, Ti |
| 00841506103518 | Threaded Peg, Non-Locking, 2.7mm x 10mm, Ti |
| 00841506103501 | Threaded Peg, Locking, 2.3mm x 32mm, Ti |
| 00841506103495 | Threaded Peg, Locking, 2.3mm x 30mm, Ti |
| 00841506103488 | Threaded Peg, Locking, 2.3mm x 28mm, Ti |
| 00841506103471 | Threaded Peg, Locking, 2.3mm x 26mm, Ti |
| 00841506103464 | Threaded Peg, Locking, 2.3mm x 24mm, Ti |
| 00841506103457 | Threaded Peg, Locking, 2.3mm x 23mm, Ti |
| 00841506103440 | Threaded Peg, Locking, 2.3mm x 22mm, Ti |
| 00841506103433 | Threaded Peg, Locking, 2.3mm x 21mm, Ti |
| 00841506103426 | Threaded Peg, Locking, 2.3mm x 20mm, Ti |
Trademark Results [Geminus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GEMINUS 85308224 4191640 Live/Registered |
SKELETAL DYNAMICS, INC. 2011-04-29 |
 GEMINUS 78661111 3501838 Dead/Cancelled |
Deutsche Bank Aktiengesellschaft 2005-06-29 |
 GEMINUS 77907718 3906598 Live/Registered |
IneoQuest Technologies, Inc. 2010-01-08 |
 GEMINUS 73517212 1369053 Dead/Cancelled |
GEMINUS DENTAL PROPHYLAXE GMBH 1985-01-11 |
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