Stablyx STX-TRAY-LID
GUDID 00841506100395
SKELETAL DYNAMICS L.L.C.
Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable| Primary Device ID | 00841506100395 |
| NIH Device Record Key | 741e72c7-67da-4cad-a6c0-e9083b0175ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stablyx |
| Version Model Number | STABLYX System Lid |
| Catalog Number | STX-TRAY-LID |
| 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 | false |
| 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 | 00841506100395 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102103
FDA Product Code
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [Stablyx]
| 00841506105765 | STABLYX System Lid |
| 00841506105758 | STABLYX Instrument Tray Insert |
| 00841506105741 | STABLYX CMC Arthroplasty System Sterilization Tray |
| 00841506105390 | STABLYX CMC Arthroplasty System |
| 00841506105383 | STABLYX, Volar Osteophyte Rasp |
| 00841506105376 | STABLYX, Volar Capsule Elevator / Shoehorn |
| 00841506105369 | STABLYX, Metacarpal Rasp, Sz. 5 |
| 00841506105352 | STABLYX, Metacarpal Rasp, Sz. 4 |
| 00841506105345 | STABLYX, Metacarpal Rasp, Sz. 3 |
| 00841506105338 | STABLYX, Metacarpal Rasp, Sz. 2 |
| 00841506105321 | STABLYX, Metacarpal Rasp, Sz. 1 |
| 00841506104584 | Awl, Straight 2.0mm |
| 00841506104577 | STABLYX, Norman Suture Passer |
| 00841506104560 | Osteotome, Curved |
| 00841506104553 | STABLYX, CMC Trial, Sz. 5 |
| 00841506104546 | STABLYX, CMC Trial, Sz. 4 |
| 00841506104539 | STABLYX, CMC Trial, Sz. 3 |
| 00841506104522 | STABLYX, CMC Trial, Sz. 2 |
| 00841506104515 | STABLYX, CMC Trial, Sz. 1 |
| 00841506104508 | STABLYX, Trapezial Contouring Tool, Sz. 1 |
| 00841506104492 | STABLYX, Trapezial Sizer, Sz. 5 |
| 00841506104485 | STABLYX, Trapezial Sizer, Sz. 4 |
| 00841506104478 | STABLYX, Trapezial Sizer, Sz. 3 |
| 00841506104461 | STABLYX, Trapezial Sizer, Sz. 2 |
| 00841506104454 | STABLYX, Trapezial Sizer, Sz. 1 |
| 00841506104447 | STABLYX, Metacarpal Planar, Sz. 1 |
| 00841506104430 | STABLYX, Metacarpal Rasp, Sz. 5 |
| 00841506104423 | STABLYX, Metacarpal Rasp, Sz. 4 |
| 00841506104416 | STABLYX, Metacarpal Rasp, Sz. 3 |
| 00841506104409 | STABLYX, Metacarpal Rasp, Sz. 2 |
| 00841506104393 | STABLYX, Metacarpal Rasp, Sz. 1 |
| 00841506104386 | STABLYX, CMC Implant, Sz. 5 |
| 00841506104379 | STABLYX, CMC Implant, Sz. 4 |
| 00841506104362 | STABLYX, CMC Implant, Sz. 3 |
| 00841506104355 | STABLYX, CMC Implant, Sz. 2 |
| 00841506104348 | STABLYX, CMC Implant, Sz. 1 |
| 00841506103303 | STABLYX, Volar Osteophyte Rasp |
| 00841506103297 | STABLYX, Volar Capsule Elevator / Shoehorn |
| 00841506103280 | STABLYX, CMC Trial, Sz. 5 |
| 00841506103273 | STABLYX, CMC Trial, Sz. 4 |
| 00841506103266 | STABLYX, CMC Trial, Sz. 3 |
| 00841506103259 | STABLYX, CMC Trial, Sz. 2 |
| 00841506103242 | STABLYX, CMC Trial, Sz. 1 |
| 00841506103235 | STABLYX, Trapezial Contouring Tool, Sz. 1 |
| 00841506103228 | STABLYX, Trapezial Sizer, Sz. 5 |
| 00841506103211 | STABLYX, Trapezial Sizer, Sz. 4 |
| 00841506103204 | STABLYX, Trapezial Sizer, Sz. 3 |
| 00841506103198 | STABLYX, Trapezial Sizer, Sz. 2 |
| 00841506103181 | STABLYX, Trapezial Sizer, Sz. 1 |
| 00841506103174 | STABLYX CMC Arthroplasty System |
Trademark Results [Stablyx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STABLYX 85200631 4376854 Live/Registered |
SKELETAL DYNAMICS, INC. 2010-12-17 |
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