Primary Device ID | 08800089452798 |
NIH Device Record Key | 6984deaa-a69b-4836-8433-baa556af4b10 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Summa Orthopaedics System Surgical Instrument |
Version Model Number | SO-111-221-2 |
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 | 08800089452798 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
[08800089452798]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-27 |
Device Publish Date | 2025-03-19 |