Primary Device ID | 00815362023228 |
NIH Device Record Key | 0ca3813e-460b-4fd3-8dd2-51055fd888be |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INTERBODY CAGES |
Version Model Number | 11085PS |
Catalog Number | 23-PC1855-12 |
Company DUNS | 079398589 |
Company Name | PRECISION SPINE, INC. |
Device Count | 1 |
DM Exempt | true |
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 | 00815362023228 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815362023228]
Moist Heat or Steam Sterilization
[00815362023228]
Moist Heat or Steam Sterilization
[00815362023228]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2016-11-15 |
00840019967969 - SureLOK MIS 3L | 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 160mm |
00840019967976 - SureLOK MIS 3L | 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 170mm |
00840019967983 - SureLOK MIS 3L | 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 180mm |
00840019967990 - SureLOK MIS 3L | 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 190mm |
00840019938693 - Reform POCT | 2024-07-25 Ø3.5 x 22mm Smooth Shank Screw - Constant Shank |
00840019938709 - Reform POCT | 2024-07-25 Ø3.5 x 26mm Smooth Shank Screw - Constant Shank |
00840019938716 - Reform POCT | 2024-07-25 Ø3.5 x 28mm Smooth Shank Screw - Constant Shank |
00840019938723 - Reform POCT | 2024-07-25 Ø3.5 x 30mm Smooth Shank Screw - Constant Shank |