SEARCH RESULTS FOR: APP企業簽[電報@S6signi-棋牌企業簽名.whi(2390 results)

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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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NexxZr™ S / Z-95-30-NS-C200-SD - 00842271100108

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42120
Not in Commercial Distribution

  • 00842271100108 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ S / Z-95-26-NS-C200-SD - 00842271100092

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42119
Not in Commercial Distribution

  • 00842271100092 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ S / Z-95-25-NS-C200-SD - 00842271100085

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42118
Not in Commercial Distribution

  • 00842271100085 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ S / Z-95-22-NS-C200-SD - 00842271100078

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42117
Not in Commercial Distribution

  • 00842271100078 ()


  • Dental appliance fabrication material, ceramic

Beurer - 00850003500478

Beurer Fertility Convenience Kit with Pearl App Each kit contains: 15 FSH test strips, 15 LH test strips, 2 hCG test strips (pregnancy test), Access (activation code) for the Pearl Fertility App.
BEURER NORTH AMERICA, L.P.
OT80
In Commercial Distribution

  • 00850003500478 ()
  • 10850003500475 ()
  • 20850003500472 ()
792.97

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

EBM - 04719878879989

No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS" App 1.2.1, Rad@
In Commercial Distribution

  • 04719878879989 ()


  • Radiological PACS software

Empatica Health Monitoring Platform - 00853858006256

No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use

GoCheck - B43056000011000

Mobile Application for Hearing Screening
Gobiquity, Inc.
Hearing Mobile App V1.0.0
In Commercial Distribution

  • B43056000011000 ()


  • Tone audiometer

BlackBox RPM - B963BPM201W1

Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

reSET-O® Demo Version (Mobile App, Android) - 10851580008248

reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008248 ()


  • Mental health/function therapeutic software, screen-viewed

reSET-O® Demo Version (Mobile App, iOS) - 10851580008231

reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008231 ()


  • Mental health/function therapeutic software, screen-viewed

reSET® Demo Version (Mobile App, Android) - 10851580008217

reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008217 ()


  • Mental health/function therapeutic software, screen-viewed

reSET® Demo Version (Mobile App, iOS) - 10851580008200

reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008200 ()


  • Mental health/function therapeutic software, screen-viewed

TPH®3 flow Liquid Micro Hybrid - D0026427151

TPH®3 flow Liquid Micro Hybrid Compula® Tip Introductory Kit
DENTSPLY INTERNATIONAL INC.
642715
Not in Commercial Distribution

  • D0026427151 ()

  • Total Volume: 0.125 Milliliter
  • 20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips
  • Weight: 0.25 Gram
642715

  • Dental composite resin

UTM-RT - 38053326009113

UTM ROOM TEMP. 1 ML W/O APP Medium for Virus, Chlamydia, Mycoplasma and Ureaplasma specimens
COPAN ITALIA SPA
3C030N.HL
In Commercial Distribution

  • 58053326009117 ()
  • 38053326009113 ()
  • 08053326009112 ()
3C030N.HL

  • General specimen container IVD, additive/medium

UTM-RT - 38053326008970

UTM ROOM TEMP.3 ML W/O APP Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens
COPAN ITALIA SPA
330C.HL
In Commercial Distribution

  • 58053326008974 ()
  • 38053326008970 ()
  • 08053326008979 ()
330C.HL

  • General specimen container IVD, additive/medium

Disposable EMG needle electrodes - 18054655015154

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=680752#
SPES MEDICA SPA
TFDN452501
In Commercial Distribution

  • 18054655015154 ()
  • 08054655015157 ()


  • Electromyographic needle electrode, single-use

2.7mm Trephine Removal - 00811954012694

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#
INTERVENTIONAL SPINE, INC
6008
In Commercial Distribution

  • 00811954012694 ()
6008

  • Bone trephine, reusable

NexxZr™ Plus / W-98-26-NP-C400-SD - 00814356021516

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22141
Not in Commercial Distribution

  • 00814356021516 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-25-NP-C400-SD - 00814356021509

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22140
Not in Commercial Distribution

  • 00814356021509 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-22-NP-C400-SD - 00814356021493

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22139
Not in Commercial Distribution

  • 00814356021493 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-20-NP-C400-SD - 00814356021486

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22138
Not in Commercial Distribution

  • 00814356021486 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-18-NP-C400-SD - 00814356021479

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22137
Not in Commercial Distribution

  • 00814356021479 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-16-NP-C400-SD - 00814356021462

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22136
Not in Commercial Distribution

  • 00814356021462 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-14-NP-C400-SD - 00814356021455

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22135
Not in Commercial Distribution

  • 00814356021455 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-12-NP-C400-SD - 00814356021448

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22134
Not in Commercial Distribution

  • 00814356021448 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-10-NP-C400-SD - 00814356021431

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22133
Not in Commercial Distribution

  • 00814356021431 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-35-NP-C300-SD - 00814356021424

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22132
Not in Commercial Distribution

  • 00814356021424 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-30-NP-C300-SD - 00814356021417

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22131
Not in Commercial Distribution

  • 00814356021417 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-26-NP-C300-SD - 00814356021400

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22130
Not in Commercial Distribution

  • 00814356021400 ()


  • Dental appliance fabrication material, ceramic
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