Rhausler C-7053-18
GUDID 08500591410490
Universal Drill Guide Spacer 18mm
Rhausler Inc.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 08500591410490 |
| NIH Device Record Key | f5a31353-8bc3-41e2-95cf-b8fc2744d7a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rhausler |
| Version Model Number | C-7053-18 |
| Catalog Number | C-7053-18 |
| Company DUNS | 015811277 |
| Company Name | Rhausler Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Device Dimensions
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
| Length | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500591410490 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042073
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
[08500591410490]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
On-Brand Devices [Rhausler]
| 08500591420536 | MD DYNAMIC PLATE 66MM, 4 LVL |
| 08500591420529 | MD DYNAMIC PLATE 63MM, 4LVL |
| 08500591420512 | MD DYNAMIC PLATE 51MM, 3 LVL |
| 08500591420499 | PLAGE BONE GRAFT IMPACTOR TOOL |
| 08500591420482 | PLAGE DRILL GUIDE HOLDER |
| 08500591420475 | PLAGE HOLDER/IMPACTOR TOOL |
| 08500591420468 | PLAGE TRIAL 17X16X10MM, GOLD LRG |
| 08500591420451 | PLAGE TRIAL 17X16X9MM, VIOLET LRG |
| 08500591420437 | PLAGE TRIAL 17X16X7MM, COPPER LRG |
| 08500591420420 | PLAGE TRIAL 17X16X6MM, BLUE LRG |
| 08500591420413 | PLAGE TRIAL 17X16X5MM, SILVER LRG |
| 08500591420406 | PLAGE TRIAL 15X14X10MM, GOLD STD |
| 08500591420383 | PLAGE TRIAL 15X14X8MM, GREEN STD |
| 08500591420369 | PLAGE TRIAL 15X14X6MM, BLUE STD |
| 08500591420352 | PLAGE TRIAL 15X14X5MM, SILVER STD |
| 08500591420321 | PLAGE TRIALS 13X14X8MM GREEN SML |
| 08500591420314 | PLAGE TRIALS 13X14X7MM COPPER SML |
| 08500591420291 | PLAGE TRIALS 13X14X5MM SILVER SML |
| 08500591420277 | PLAGE RASP 17X16X9MM, VIOLET LRG |
| 08500591420260 | PLAGE RASP 17X16X8MM, GREEN LRG |
| 08500591420253 | PLAGE RASP 17X16X7MM, COPPER LRG |
| 08500591420246 | PLAGE RASP 17X16X6MM, BLUE LRG |
| 08500591420222 | PLAGE RASP 15X14X10MM, GOLD STD |
| 08500591420215 | PLAGE RASP 15X14X9MM, VIOLET STD |
| 08500591420185 | PLAGE RASP 15X14X6MM, BLUE STD |
| 08500591420178 | PLAGE RASP 15X14X5MM, SILVER STD |
| 08500591420161 | PLAGE SERRATED RASP 13X14X10MM GOLD SML |
| 08500591420154 | PLAGE SERRATED RASP 13X14X9MM VIOLET SML |
| 08500591420130 | PLAGE SERRATED RASP 13X14X7 COPPER SML |
| 08500591420123 | PLAGE SERRATED RASP 13X14X6MM BLUE SML |
| 08500591420116 | PLAGE SERRATED RASP 13X14X5MM SILVER SML |
| 08500591420109 | PLAGE DRILL GUIDE GOLD LRG 0 DEG |
| 08500591420086 | PLAGE DRILL GUIDE GREEN LRG 0 DEG |
| 08500591420079 | PLAGE DRILL GUIDE COPPER LRG 0 DEG |
| 08500591420062 | PLAGE DRILL GUIDE BLUE LRG 0 DEG |
| 08500591420055 | PLAGE DRILL GUIDE SILVER LRG 0 DEG |
| 08500591420048 | PLAGE DRILL GUIDE GOLD S-STD 0 DEG |
| 08500591420024 | PLAGE DRILL GUIDE GREEN S-STD 0 DEG |
| 08500591420017 | PLAGE DRILL GUIDE COPPER S-STD 0 DEG |
| 08500591410995 | PLAGE DRILL GUIDE SILVER S-STD 0 DEG |
| 08500591410988 | PLAGE LORDO 17X16X10MM GOLD LRG 0 DEG |
| 08500591410971 | PLAGE LORDO 17X16X9MM VIOLET LRG 0 DEG |
| 08500591410957 | PLAGE LORDO 17X16X7MM COPPER LRG 0 DEG |
| 08500591410940 | PLAGE LORDO 17X16X6MM BLUE LRG 0 DEG |
| 08500591410933 | PLAGE LORDO 17X16X5MM SILVER LRG 0 DEG |
| 08500591410926 | PLAGE LORDO 15X14X10MM GOLD STD 6 DEG |
| 08500591410902 | PLAGE LORDO 15X14X8MM GREEN STD 6 DEG |
| 08500591410896 | PLAGE LORDO 15X14X7MM COPPER STD 6 DEG |
| 08500591410872 | PLAGE LORDO 15X14X5MM SILVER STD 6 DEG |
| 08500591410858 | PLAGE LORDO 15X14X9MM VIOLET STD 0 DEG |
Trademark Results [Rhausler]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RHAUSLER 86130893 4668586 Live/Registered |
RHAUSLER, Inc. 2013-11-27 |
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