Primary Device ID | 08806390875394 |
NIH Device Record Key | 3e80f6d0-e160-40b3-ab2e-45ddf250d1e3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Summa Orthopaedics System Surgical Instrument |
Version Model Number | SO-111-197 |
Company DUNS | 688811603 |
Company Name | Jeil Medical Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 | 08806390875394 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
[08806390875394]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-06-12 |
Device Publish Date | 2018-12-05 |