First Aid Kit With Drug

Device Code: 5931

Product Code(s): LRR

Definition: Note: In Addition To Compliance With Our Convenience Kit Guidance, In Regards To Any Drug Products Contained In This Kit Compliance With The Center For Drug Evaluation Is Required As Well. Www.fda.gov/cder/index.html - This Product Code Has Been Esta

Device Classification Information

Device Type ID5931
Device NameFirst Aid Kit With Drug
Physical StateNote: In Addition To Compliance With Our Convenience Kit Guidance, In Regards To Any Drug Products Contained In This Kit Compliance With The Center For Drug Evaluation Is Required As Well. Www.fda.gov/cder/index.html - This Product Code Has Been Esta
Technical MethodNote: In Addition To Compliance With Our Convenience Kit Guidance, In Regards To Any Drug Products Contained In This Kit Compliance With The Center For Drug Evaluation Is Required As Well. Www.fda.gov/cder/index.html - This Product Code Has Been Esta
Target AreaNote: In Addition To Compliance With Our Convenience Kit Guidance, In Regards To Any Drug Products Contained In This Kit Compliance With The Center For Drug Evaluation Is Required As Well. Www.fda.gov/cder/index.html - This Product Code Has Been Esta
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission TypeEnforcement Discretion
FDA Device ClassificationClass Not Classified Medical Device
Product CodeLRR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5931
DeviceFirst Aid Kit With Drug
Product CodeLRR
Recalls
Manufacturer Recall Class Date Posted
1
Certified Safety Mfg Inc
II Apr-11-2018
TPLC Last Update: 2019-04-02 21:14:47

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