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  5. UDI Exceptions, Alternatives and Time Extensions - Section
  6. FDA Product Codes for UDI Alternative UDI-A160001
  1. UDI Exceptions, Alternatives and Time Extensions - Section

FDA Product Codes for UDI Alternative UDI-A160001

Version 1.7: November 5, 2021

FDA Product Code FDA Product Code Name Regulation (21 CFR)
EBO Over the Counter Denture Repair Kit 872.3570
EBP Reliner, Denture, Over the Counter 872.3560
EMA Cement, Dental 872.3275
FLK Thermometer, Clinical Mercury 880.2920
FLL Thermometer, Electronic, Clinical 880.2910
FMF Syringe, Piston 880.5860
FMI Needle, Hypodermic, Single Lumen 880.5570
FRO Dressing, Wound, Drug N/A
GZJ
Added 11/5/21		 Stimulator, Nerve, Transcutaneous, for Pain Relief  882.5890 
HEB Tampon, Menstrual, Unscented 884.5470
HHE Cup, Menstrual 884.5400
HHW Pessary, Vaginal 884.3575
HIL Tampon, Menstrual, Scented, Deodorized 884.5460
HIS Condom 884.5300
ILY Lamp, Infrared, Therapeutic Heating 890.5500
KKO Ring, Teething, Fluid-Filled 872.5550
LBH Varnish, Cavity 872.3260
LCX Kit, Test, Pregnancy, hCG, Over the Counter 862.1155
LDJ Enzyme Immunoassay, Cannabinoids 862.3870
LFD Saliva, Artificial N/A
LKY Device, External Penile Rigidity 876.5020
LPN Accessories, Soft Lens Products 886.5928
LRR First Aid Kit with Drug N/A
LRX Case, Contact Lens 886.5928
LTZ Condom with Nonoxynol-9 884.5310
LYL Accessories, Solution, Ultrasonic Cleansers for Lenses 886.5928
MNW Analyzer, Body Composition 870.2770
MOL Condom, Synthetic 884.5300
MRC Products, Contact Lens Care, Rigid Gas Permeable 886.5918
NUC Lubricant, Personal 884.5300
NUH Simulator, Nerve, Transcutaneous, Over-the-Counter 882.5890
OBR
Added 11/5/21		 Mouthguard, Over-the-Counter N/A
OHT Light Based Over-the-Counter Hair Removal 878.4810
PEB Lubricant, Personal, Gamete, Fertilization, and Embryo Compatible 884.5300
POV
 		 Semen Analysis Device 864.5220

FDA Product Codes for UDI Alternative UDI-A160001 - Document History

Version Date Change
1.0 August 19, 2016 Original
1.1 September 6, 2016 Added the following FDA Product Codes: FLK, FLL, LPN, LRX, LYL, and MRC
1.2 October 5, 2016 Added the following FDA Product Code: MNW
1.3 November 30, 2016 Added the following FDA Product Code: ILY
1.4 January 11, 2017 Added the following FDA Product Code: POV
1.5 January 4, 2018 Added the following FDA Product Code: LFD
1.6 June 28, 2018 Added the following FDA Product Code: HHE
1.7 November 5, 2021 Added the following FDA Product Codes: GZJ and OBR
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