PYRAMESH® Implant System
GUDID 00721902973048
25MM X 150MM CURVED ROUND MESH
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00721902973048 |
| NIH Device Record Key | 48a88aa4-1ae5-4f66-a6f8-e0b2287569c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYRAMESH® Implant System |
| Version Model Number | X905-904 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| 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)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00721902973048 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K923419
FDA Product Code
| JEY | PLATE, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
[00721902973048]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-05 |
On-Brand Devices [PYRAMESH® Implant System]
| 00613994133038 | CYLINDER X110531332 ROUND MESH 13X32 |
| 00681490844420 | PYRAMESH 14 X 10 X 24MM |
| 00681490844413 | PYRAMESH 12 X 10 X 24MM |
| 00681490844406 | PYRAMESH 10 X 10 X 24MM |
| 00681490844390 | PYRAMESH 8 X 10 X 24MM |
| 00681490844383 | MESH 9050020 PYRAMESH 20MM |
| 00681490844376 | MESH 9050018 PYRAMESH 18MM |
| 00681490844369 | MESH 9050016 PYRAMESH 16MM |
| 00681490844352 | MESH 9050014 PYRAMESH 14MM |
| 00681490844345 | PYRAMESH 12MM |
| 00681490484756 | MESH 9052830 PYRAMESH IMP 22MMX28MMX30MM |
| 00681490484749 | MESH 9052815 PYRAMESH IMP 22MMX28MMX15MM |
| 00681490484732 | MESH 9052518 PYRMSH IMPL 25MM AGL 13X18 |
| 00681490484718 | MESH 9052318 PYMSH IMPL 23X27 AGL 13X18 |
| 00681490484701 | MESH 9052315 PYMSH IMPL 23X27 AGL 10X15 |
| 00681490484664 | MESH 9052230 PYRAMESH IMPLT 22MMX30MM RD |
| 00681490484640 | MESH 9052215 PYRAMESH IMPLT 22MMX15MM RD |
| 00681490484633 | MESH 9052208 PYRMSH IMPL 22MM AGL 13X18 |
| 00681490484626 | MESH 9052205 PYRMSH IMPL 22MM AGL 10X15 |
| 00681490484619 | MESH 9051918 PYRMSH IMPL 19MM AGL 13X18 |
| 00681490484602 | MESH 9051915 PYRMSH IMPL 19MM AGL 10X15 |
| 00681490484541 | MESH 9051715 PYRAMESH IMP 17MMX22MMX15MM |
| 00681490484534 | MESH 9051710 PYRAMESH IMP 17MMX22MMX10MM |
| 00681490484497 | MESH 9051315 PYRM IMPLANT 13MMX15MM RND |
| 00681490484480 | MESH 9051314 PYRM IMPLANT 13MMX14MM RND |
| 00681490484473 | MESH 9051050 PYRAMESH IMP 10MMX50MM RND |
| 00681490484466 | MESH 9051014 PYRM IMPLANT 10MMX14MM RND |
| 00681490484459 | MESH 9051013 PYRM IMPLANT 10MMX13MM RND |
| 00681490484442 | MESH 9051011 PYRM IMPLANT 10MMX11MM RND |
| 00681490484435 | MESH 9051009 PYRM IMPLANT 10MMX 9MM RND |
| 00681490484237 | MESH 9050514 PYRM IMPL 13MMX17MMX14MM |
| 00681490484220 | MESH 9050513 PYRM IMPL 13MMX17MMX13MM |
| 00681490484206 | MESH 9050414 PYRM IMPL 10MMX14MMX14MM |
| 00681490484190 | MESH 9050413 PYRM IMPL 10MMX14MMX13MM |
| 00673978081311 | MESH 905-904 PYRM 25 X 150 ANGLED |
| 00673978081304 | MESH 905-903 PYRM 19 X 150 ANGLED |
| 00673978081298 | MESH 905-902 PYRM 10X14 OVOIDX130MM CRV |
| 00673978081281 | MESH 905-901 PYRM 13MM X 130MM CURVED |
| 00673978081106 | MESH 905-615 PYRM 16MM X 15MM ROUND |
| 00673978081090 | MESH 905-612 PYRM 16MM X 12MM ROUND |
| 00673978081083 | MESH 905-611 PYRM 16MM X 11MM ROUND |
| 00673978081076 | MESH 905-609 PYRM 16MM X 9MM ROUND |
| 00673978081069 | MESH 905-608 PYRM 16MM X 8MM ROUND |
| 00673978081052 | MESH 905-520 PYRM 13 X 17 OVOID X 20MM |
| 00673978081045 | MESH 905-515 PYRM 13 X 17 OVOID X 15MM |
| 00673978081038 | MESH 905-512 PYRM 13 X 17 OVOID X 12MM |
| 00673978081021 | MESH 905-511 PYRM 13 X 17 OVOID X 11MM |
| 00673978081014 | MESH 905-509 PYRM 13 X 17 OVOID X 9MM |
| 00673978081007 | MESH 905-508 PYRM 13 X 17 OVOID X 8MM |
| 00673978080970 | MESH 905-501 PYRM 13 X17 X 10 OVOID |
Trademark Results [PYRAMESH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PYRAMESH 75334348 2242033 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1997-08-01 |
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