Primary Device ID | 07640164849614 |
NIH Device Record Key | 580074b3-09f6-49ce-b46d-d3c6e00254e6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | icotec Pedicle System 6.0, Screw, Ti, Polyax., Fen., Ø 8.5 x 55 mm |
Version Model Number | 16-6022-98555 |
Company DUNS | 480789465 |
Company Name | icotec AG |
Device Count | 1 |
DM Exempt | true |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +41717570000 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 07640164849614 [Primary] |
PML | Bone Cement, Posterior Screw Augmentation |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-11-04 |
Device Publish Date | 2020-10-27 |
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07640172551967 - VADER Pedicle System, Handle, 1/4" Coupling | 2025-08-07 VADER Pedicle System, Handle, 1/4" Coupling |
07640172551981 - VADER Pedicle System, Deburring tool | 2025-08-07 VADER Pedicle System, Deburring tool |
07640172551998 - VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm | 2025-08-07 VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm |