Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BTE OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0019-02
In Commercial Distribution

  • 00850049194112 ()


  • Air-conduction hearing aid, behind-the-ear
BTE OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0019-01
In Commercial Distribution

  • 00850049194105 ()


  • Air-conduction hearing aid, behind-the-ear
Lucid Hearing OTC Hearing Protection #20055
ETYMOTIC RESEARCH, INC.
Lucid Hearing OTC #20055
In Commercial Distribution

  • 00846430005662 ()


  • Earplugs, reusable
Tubing,Motor,Long,A-dec 501,OTC
A-DEC, INC.
54.0854.01
In Commercial Distribution

  • 10194665005603 ()
54.0854.01

  • Remotely-driven surgical/dental system drive cable
Tubing,Motor,Medium,A-dec 501,OTC
A-DEC, INC.
54.0853.01
In Commercial Distribution

  • 10194665005580 ()
54.0853.01

  • Remotely-driven surgical/dental system drive cable
Tubing,Motor,Short,A-dec 501,OTC
A-DEC, INC.
54.0852.01
In Commercial Distribution

  • 10194665005573 ()
54.0852.01

  • Remotely-driven surgical/dental system drive cable
Kit,Tubing ASSY,Long,Kavo,OTC
A-DEC, INC.
54.0808.01
In Commercial Distribution

  • 10194665005511 ()
54.0808.01

  • Remotely-driven surgical/dental system drive cable
Kit,Tubing ASSY,Medium,Kavo,OTC
A-DEC, INC.
54.0807.01
In Commercial Distribution

  • 10194665005504 ()
54.0807.01

  • Remotely-driven surgical/dental system drive cable
Tubing,Control Motor,Long,Kavo,OTC
A-DEC, INC.
54.0847.00
In Commercial Distribution

  • 10194665004163 ()
54.0847.00

  • Dental surgical power tool motor, electric
Tubing,Control Motor,Medium,Kavo,OTC
A-DEC, INC.
54.0846.00
In Commercial Distribution

  • 10194665004149 ()
54.0846.00

  • Dental surgical power tool motor, electric
Electric Motor,Nano,68 IN,OTC
A-DEC, INC.
54.0727.01
In Commercial Distribution

  • 10194665001278 ()
54.0727.01

  • Dental surgical power tool motor, electric
Electric Motor,Nano,61 IN,OTC
A-DEC, INC.
54.0446.01
In Commercial Distribution

  • 10194665000813 ()
54.0446.01

  • Dental surgical power tool motor, electric
Safer Lock - Rx Locking Cap OTC
Rxguardian Inc.
1000092
In Commercial Distribution

  • 00860002613611 ()


  • Medicine bottle
  • Medicine bottle cap
1T, FDA OTC, Without Absorbent wick
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155151 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
1T, cut-off:1ng/ml,FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A1617
In Commercial Distribution

  • 06936983148504 ()
DISP-FY-102H

  • Fentanyl IVD, kit, rapid ICT, clinical
OTC, HEARING AID, BEHIND EAR, WT
MEDLINE INDUSTRIES, INC.
MDSHEARAIDWT1
In Commercial Distribution

  • 00197344013275 ()

  • Width: 10.5 Millimeter
  • Length: 33.1 Millimeter
  • MDSHEARAIDWT
MDSHEARAIDWT1

  • Air-conduction hearing aid, behind-the-ear
OTC, HEARING AID, IN EAR, BLACK
MEDLINE INDUSTRIES, INC.
MDSHEARAIDBK1
In Commercial Distribution

  • 20197344013248 ()
  • 00197344013244 ()
  • 80197344013240 ()
MDSHEARAIDBK1

  • Air-conduction hearing aid, in-the-ear
FEEDING SYRINGE, ENFIT, FLT TP, OTC
MEDLINE INDUSTRIES, INC.
ENFIT70660
In Commercial Distribution

  • 40193489036658 ()
  • 00193489036650 ()
ENFIT70660

  • ENFit oral/enteral syringe, single-use
OTC Single Use urinary test strip
REESE PHARMACEUTICAL COMPANY
UTES
In Commercial Distribution

  • 00023513000039 ()
  • 00036800468450 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
OTC Single Use urinary test strip
REESE PHARMACEUTICAL COMPANY
UTES
In Commercial Distribution

  • 00023513487441 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
QuikClot Bleeding Control Bag, OTC,SOFTT-W
Z-MEDICA, LLC
0622
In Commercial Distribution

  • 00841495106224 ()
0622

  • Non-organic haemostatic agent
QuikClot Bleeding Control Bag, OTC, CAT
Z-MEDICA, LLC
0621
In Commercial Distribution

  • 00841495106217 ()
0621

  • Non-organic haemostatic agent
QuikClot Bleeding Control Kit, OTC, SOFTT-W
Z-MEDICA, LLC
0612
In Commercial Distribution

  • 00841495106125 ()
0612

  • Non-organic haemostatic agent
QuikClot Bleeding Control Kit, OTC, CAT
Z-MEDICA, LLC
0611
In Commercial Distribution

  • 00841495106118 ()
0611

  • Non-organic haemostatic agent
Procellera Single Layer OTC, 2"x2"
Vomaris Wound Care, Inc.
2"x 2"
In Commercial Distribution

  • 00810198030372 ()
VSC-0202

  • Bioelectric wound dressing
Mepilex Border Lite 10x10cm, OTC US
Mölnlycke Health Care AB
281300
In Commercial Distribution

  • 07323190049165 ()
  • 07332430529022 ()
  • 07323190049158 ()

  • 10cm x 10cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex Border Lite 7,5x7,5cm, OTC US
Mölnlycke Health Care AB
281200
In Commercial Distribution

  • 07323190048892 ()
  • 07332430529008 ()
  • 07323190048885 ()

  • 7.5cm x 7.5cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex Border Lite 4x5cm, OTC US
Mölnlycke Health Care AB
281000
In Commercial Distribution

  • 07323190246618 ()
  • 07323190246625 ()
  • 07332430520395 ()

  • 4cm x 5cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex Border Flex 10x10cm, OTC US
Mölnlycke Health Care AB
595333
In Commercial Distribution

  • 07333350089757 ()
  • 07333350881245 ()
  • 07333350732097 ()

  • 10x10cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Quell 2.0 Relief Replacement Device (OTC)
NEUROMETRIX, INC.
QE-NAS-RPL
In Commercial Distribution

  • 00851221006803 ()


  • Analgesic transcutaneous electrical nerve stimulation system
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