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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The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Shenzhen Konmed Technology Co., Ltd.
KM-802
In Commercial Distribution

  • 06970935830109 ()


  • Transcutaneous electrical stimulation electrode, single-use
The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Shenzhen Konmed Technology Co., Ltd.
KM-801
In Commercial Distribution

  • 06970935830093 ()


  • Transcutaneous electrical stimulation electrode, single-use
The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Shenzhen Konmed Technology Co., Ltd.
KM-808
In Commercial Distribution

  • 06970935830086 ()


  • Transcutaneous electrical stimulation electrode, single-use
The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Shenzhen Konmed Technology Co., Ltd.
KM-803
In Commercial Distribution

  • 06970935830079 ()


  • Transcutaneous electrical stimulation electrode, single-use
Impression Taking Traveler Kit International
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788511 ()
10168

  • Earmould impression material
Impression Taking Traveler Kit
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788504 ()
10166

  • Earmould impression material
Impression Taking Refill Kit International
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788498 ()
10164

  • Earmould impression material
Impression Taking Starter Kit
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788481 ()
10163

  • Earmould impression material
Impression Taking Refill Kit - Refill for Impression taking kit
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788474 ()
10162

  • Earmould impression material
Impression Taking Starter Kit
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788467 ()
10161

  • Earmould impression material
Blue Silicast Hardener
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788436 ()
10402

  • Earmould impression material
Blue Silicast 700g
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788429 ()
10401

  • Earmould impression material
EZ Mold 8oz Tub Set Forest Green
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788412 ()
10391

  • Earmould impression material
EZ Mold 8oz Tub Set Red
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788405 ()
10389

  • Earmould impression material
EZ Mold 8oz Tub Set Brown
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788399 ()
10388

  • Earmould impression material
EZ Mold 8oz Tub Set Blue
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788382 ()
10387

  • Earmould impression material
EZ Mold 8oz Tub Set Green
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788375 ()
10386

  • Earmould impression material
EZ Mold 8oz Tub Set Yellow
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788368 ()
10385

  • Earmould impression material
EZ Mold 8oz Tub Set Orange
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788351 ()
10384

  • Earmould impression material
EZ Mold 8oz Tub Set Purple
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788344 ()
10383

  • Earmould impression material
EZ Mold 8oz Tub Set Pink
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788337 ()
10382

  • Earmould impression material
EZ Mold 8oz Tub Set Beige
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788320 ()
10381

  • Earmould impression material
EZ Mold 8oz Tub Set Black
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788313 ()
10380

  • Earmould impression material
EZ Mold Singles 22 Pk Assorted
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788306 ()
10342

  • Earmould impression material
EZ Mold Singles 24 Pk Forest Green
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788290 ()
10341

  • Earmould impression material
EZ Mold Singles 24 Pk Red
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788283 ()
10339

  • Earmould impression material
EZ Mold Singles 24 Pk Brown
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788276 ()
10338

  • Earmould impression material
EZ Mold Singles 24 Pk Blue
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788269 ()
10337

  • Earmould impression material
EZ Mold Singles 24 Pk Green
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788252 ()
10336

  • Earmould impression material
EZ Mold Singles 24 Pk Yellow
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788245 ()
10335

  • Earmould impression material
EZ Mold Singles 24 Pk Orange
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788238 ()
10334

  • Earmould impression material
EZ Mold Singles 24 Pk Purple
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788221 ()
10333

  • Earmould impression material
EZ Mold Singles 24 Pk Pink
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788214 ()


  • Earmould impression material
EZ Mold Singles 24 Pk Beige
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788207 ()
10331

  • Earmould impression material
EZ Mold Single, Black 24 pack
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788191 ()
10330

  • Earmould impression material
Pink Silicast Impression Material - two 525g tubs
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788184 ()
10302

  • Earmould impression material
Pink Silicast Impression Material - two 335g tubs
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788177 ()
10301

  • Earmould impression material
Earmold Impression Material 100 package
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788160 ()
10205

  • Earmould impression material
Earmold Impression material 24 Package
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788153 ()
10203

  • Earmould impression material
SiliClone FIRM 8pk - 32 tips
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788108 ()
10184

  • Earmould impression material
SiliClone FIRM 8pk - no tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788092 ()
10183

  • Earmould impression material
SiliClone FIRM - 4 tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788085 ()
10182

  • Earmould impression material
SiliClone S-50 8pk - 32 Tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788078 ()
10154

  • Earmould impression material
SiliClone S-50 8pk - no tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788061 ()
10153

  • Earmould impression material
SiliClone S-50 - 4 tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788054 ()
10152

  • Earmould impression material
SiliClone S-50 - no tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788047 ()
10151

  • Earmould impression material
SiliClone S-50 Starter Pack Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788030 ()
10132

  • Earmould impression material
Siliclone X-Act 8pk 32 tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788023 ()
10114

  • Earmould impression material
Siliclone X-Act 8pk No tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788016 ()
10113

  • Earmould impression material
Siliclone X-Act with 4 Tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788009 ()
10112

  • Earmould impression material
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