Primary Device ID | 08800037560780 |
NIH Device Record Key | ebb93052-0316-43c9-a071-7900a8699fc3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Global Spinal Fixation System™ |
Version Model Number | SG2200 |
Company DUNS | 688811082 |
Company Name | U&I CORPORATION |
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 | true |
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 | 08800037560780 [Primary] |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
[08800037560780]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-03-06 |
Device Publish Date | 2023-02-25 |