MONARCH 177050145
GUDID 10705034057231
MONARCH SPINE SYSTEM SLOTTED CONNECTOR WITH WASHER, MINI-OFFSET, RIGHT 6.35mm
DEPUY SPINE, LLC
Implantable bone washer| Primary Device ID | 10705034057231 |
| NIH Device Record Key | 681f5dbd-4d9f-4988-9e2f-31f5437d9abe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONARCH |
| Version Model Number | 177050145 |
| Catalog Number | 177050145 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, LLC |
| 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
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034057231 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K010576
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
[10705034057231]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-29 |
| Device Publish Date | 2024-07-19 |
On-Brand Devices [MONARCH]
| 10705034059853 | MONARCH SPINE SYSTEM DUAL CONNECTOR, CLOSED, SIDE, 6.35 X 4.75mm |
| 10705034197104 | MONARCH SPINE SYSTEM REDUCTION INSTRUMENT |
| 10705034196923 | MONARCH SPINE SYSTEM DISTRACTOR 5.5mm |
| 10705034196916 | MONARCH SPINE SYSTEM DISTRACTOR 6.35mm |
| 10705034196886 | MONARCH SPINE SYSTEM CAP INSERTER, SHORT |
| 10705034196879 | MONARCH SPINE SYSTEM CAP INSERTER |
| 10705034196701 | MONARCH SPINE SYSTEM WASHER,INSERTER,SPACER |
| 10705034196633 | MONARCH SPINE SYSTEM RATCHETING ROD CLAMP 6.35mm |
| 10705034196374 | MONARCH SPINE SYSTEM MODULAR SPHERICAL HANDLE |
| 10705034301099 | MONARCH SPINE SYSTEM HOOK HOLDER |
| 10705034197159 | MONARCH SPINE SYSTEM HOOK HOLDER,CLOSED,STRAIGHT |
| 10705034197128 | MONARCH SPINE SYSTEM OPEN HOOK HOLDER,OFFSET |
| 10705034197111 | MONARCH SPINE SYSTEM OPEN HOOK HOLDER,OFFSET |
| 10705034197036 | MONARCH SPINE SYSTEM SCREW ALIGNMENT GUIDE |
| 10705034196619 | MONARCH SPINE SYSTEM ROD HOLDER |
| 10705034196602 | MONARCH SPINE SYSTEM ROD HOLDER |
| 10705034196596 | MONARCH SPINE SYSTEM STRAIGHT FORCEP ROD HOLDER 6.35mm |
| 10705034301181 | MONARCH SPINE SYSTEM SCREW CADDY 5.5mm |
| 10705034198071 | MONARCH SPINE SYSTEM HOOK CASE |
| 10705034198064 | MONARCH SPINE SYSTEM INSTRUMENT TRAY |
| 10705034198057 | MONARCH SPINE SYSTEM INSTRUMENT TRAY |
| 10705034198040 | MONARCH SPINE SYSTEM INSTRUMENT CASE |
| 10705034198033 | MONARCH SPINE SYSTEM SCREW CADDY 8.5mm |
| 10705034198026 | MONARCH SPINE SYSTEM SCREW CADDY 7.75mm |
| 10705034198019 | MONARCH SPINE SYSTEM SCREW CADDY 7mm |
| 10705034198002 | MONARCH SPINE SYSTEM SCREW CADDY 6.25mm |
| 10705034197999 | MONARCH SPINE SYSTEM SCREW CADDY 4.75mm |
| 10705034197982 | MONARCH SPINE SYSTEM SCREW TRAY |
| 10705034197975 | MONARCH SPINE SYSTEM SLOTTED CONNECTOR CADDIE |
| 10705034197968 | MONARCH SPINE SYSTEM CADDY 6.35 |
| 10705034197951 | MONARCH SPINE SYSTEM MCC CADDIE 5.50mm |
| 10705034197944 | MONARCH SPINE SYSTEM IMPLANT CASE |
| 10705034197548 | MONARCH SPINE SYSTEM HOOK CASE |
| 10705034197531 | MONARCH SPINE SYSTEM SCREW CADDY 7.75mm / 8.5mm |
| 10705034197517 | MONARCH SPINE SYSTEM POLY SCREW INSTRUMENT TRAY |
| 10705034197500 | MONARCH SPINE SYSTEM N/C/STD SCREW INSTRUMENT TRAY |
| 10705034197470 | MONARCH SPINE SYSTEM LOW BACK CORE INSTRUMENT CASE |
| 10705034197463 | MONARCH SPINE SYSTEM SCREW CADDY 7mm |
| 10705034197456 | MONARCH SPINE SYSTEM SCREW CADDY 6.25mm |
| 10705034197449 | MONARCH SPINE SYSTEM SCREW CADDY 5.5mm |
| 10705034197432 | MONARCH SPINE SYSTEM SCREW CADDY 4.75mm |
| 10705034197425 | MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 8.50mm |
| 10705034197418 | MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 7.75mm |
| 10705034197401 | MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 7.0mm |
| 10705034197395 | MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 6.25mm |
| 10705034197388 | MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 5.50mm |
| 10705034197371 | MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 4.75mm |
| 10705034197364 | MONARCH SPINE SYSTEM POLYAXIAL/HOOK CAP CADDIE |
| 10705034197357 | MONARCH SPINE SYSTEM STANDARD SCREW CADDIE 8.50mm |
| 10705034197340 | MONARCH SPINE SYSTEM STANDARD SCREW CADDIE 7.75mm |
Trademark Results [MONARCH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MONARCH 98840620 not registered Live/Pending |
Brio Water Technology, Inc. 2024-11-06 |
 MONARCH 98840615 not registered Live/Pending |
Brio Water Technology, Inc. 2024-11-06 |
 MONARCH 98840607 not registered Live/Pending |
Brio Water Technology, Inc. 2024-11-06 |
 MONARCH 98771077 not registered Live/Pending |
Australian Brushware Corporation Pty Ltd 2024-09-26 |
 MONARCH 98771065 not registered Live/Pending |
Australian Brushware Corporation Pty Ltd 2024-09-26 |
 MONARCH 98698052 not registered Live/Pending |
ROLLER DERBY SKATE CORPORATION 2024-08-14 |
 MONARCH 98614090 not registered Live/Pending |
Runnestoe, Ingunn 2024-06-22 |
MONARCH 98614090 not registered Live/Pending |
Reyes, Christopher 2024-06-22 |
 MONARCH 98587522 not registered Live/Pending |
American Printing House for the Blind 2024-06-06 |
 MONARCH 98524223 not registered Live/Pending |
American Printing House for the Blind 2024-04-29 |
 MONARCH 98502412 not registered Live/Pending |
LEGEND IP HOLDINGS PRODUCTION, LLC 2024-04-16 |
 MONARCH 98502404 not registered Live/Pending |
LEGEND IP HOLDINGS PRODUCTION, LLC 2024-04-16 |
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