Primary Device ID | 10889981310417 |
NIH Device Record Key | f60f36aa-b60b-484b-8c45-0eed1d869121 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Meridian |
Version Model Number | RA1-504315 |
Catalog Number | RA1-504315 |
Company DUNS | 079840876 |
Company Name | SEASPINE ORTHOPEDICS CORPORATION |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10889981310417 [Primary] |
OVD | Intervertebral fusion device with integrated fixation, lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
[10889981310417]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-23 |
Device Publish Date | 2024-05-15 |
10889981214272 | Anterior Plate Locking Cover, 10mm |
10889981259549 | Spin Plate, 39mm x 30mm x 8mm |
10889981259532 | Spin Plate, 39mm x27mm x 8mm |
10889981259525 | Spin Plate, 35mm x 27mm x 8mm |
10889981259518 | Spin Plate, 31mm x 24mm x 8mm |
10889981247676 | Torque Limiting T-Handle, 29inlb |
10889981247652 | No-Profile Interbody, 43mm x 30mm x 20mm, 30 Deg |
10889981247645 | No-Profile Interbody, 43mm x 30mm x 20mm, 25 Deg |
10889981247638 | No-Profile Interbody, 43mm x 30mm x 20mm, 20 Deg |
10889981247621 | No-Profile Interbody, 43mm x 30mm x 20mm, 15 Deg |
10889981247614 | No-Profile Interbody, 43mm x 30mm x 20mm, 10 Deg |
10889981247607 | No-Profile Interbody, 43mm x 30mm x 18mm, 30 Deg |
10889981247591 | No-Profile Interbody, 43mm x 30mm x 18mm, 25 Deg |
10889981247584 | No-Profile Interbody, 43mm x 30mm x 18mm, 20 Deg |
10889981247577 | No-Profile Interbody, 43mm x 30mm x 18mm, 15 Deg |
10889981247560 | No-Profile Interbody, 43mm x 30mm x 18mm, 10 Deg |
10889981247553 | No-Profile Interbody, 43mm x 30mm x 16mm, 30 Deg |
10889981247546 | No-Profile Interbody, 43mm x 30mm x 16mm, 25 Deg |
10889981247539 | No-Profile Interbody, 43mm x 30mm x 16mm, 20 Deg |
10889981247522 | No-Profile Interbody, 43mm x 30mm x 16mm, 15 Deg |
10889981247515 | No-Profile Interbody, 43mm x 30mm x 16mm, 10 Deg |
10889981247508 | No-Profile Interbody, 43mm x 30mm x 14mm, 25 Deg |
10889981247492 | No-Profile Interbody, 43mm x 30mm x 14mm, 20 Deg |
10889981247485 | No-Profile Interbody, 43mm x 30mm x 14mm, 15 Deg |
10889981247478 | No-Profile Interbody, 43mm x 30mm x 14mm, 10 Deg |
10889981247461 | No-Profile Interbody, 43mm x 30mm x 12mm, 20 Deg |
10889981247454 | No-Profile Interbody, 43mm x 30mm x 12mm, 15 Deg |
10889981247447 | No-Profile Interbody, 43mm x 30mm x 12mm, 10 Deg |
10889981247430 | No-Profile Interbody, 43mm x 30mm x 10mm, 15 Deg |
10889981247423 | No-Profile Interbody, 43mm x 30mm x 10mm, 10 Deg |
10889981247416 | No-Profile Interbody, 39mm x 30mm x 20mm, 30 Deg |
10889981247409 | No-Profile Interbody, 39mm x 30mm x 20mm, 20 Deg |
10889981247393 | No-Profile Interbody, 39mm x 30mm x 20mm, 15 Deg |
10889981247386 | No-Profile Interbody, 39mm x 30mm x 20mm, 10 Deg |
10889981247379 | No-Profile Interbody, 39mm x 30mm x 18mm, 30 Deg |
10889981247362 | No-Profile Interbody, 39mm x 30mm x 18mm, 15 Deg |
10889981247355 | No-Profile Interbody, 39mm x 30mm x 18mm, 10 Deg |
10889981247348 | No-Profile Interbody, 39mm x 30mm x 16mm, 30 Deg |
10889981247331 | No-Profile Interbody, 39mm x 30mm x 16mm, 25 Deg |
10889981247324 | No-Profile Interbody, 39mm x 30mm x 14mm, 25 Deg |
10889981247317 | No-Profile Interbody, 39mm x 30mm x 12mm, 20 Deg |
10889981247300 | No-Profile Interbody, 39mm x 30mm x 10mm, 15 Deg |
10889981247294 | No-Profile Interbody, 39mm x 27mm x 20mm, 30 Deg |
10889981247287 | No-Profile Interbody, 39mm x 27mm x 20mm, 20 Deg |
10889981247270 | No-Profile Interbody, 39mm x 27mm x 20mm, 15 Deg |
10889981247263 | No-Profile Interbody, 39mm x 27mm x 20mm, 10 Deg |
10889981247256 | No-Profile Interbody, 39mm x 27mm x 18mm, 30 Deg |
10889981247249 | No-Profile Interbody, 39mm x 27mm x 18mm, 15 Deg |
10889981247232 | No-Profile Interbody, 39mm x 27mm x 18mm, 10 Deg |
10889981247225 | No-Profile Interbody, 39mm x 27mm x 16mm, 30 Deg |