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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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The George Gauge Kit - D7750560501

Ideal for mandibular repositioning, the George Gauge allows the clinician to capture the protrusive bite registration and vertical opening without relying on the patient to achieve proper positioning. Eliminates guesswork. Extremely accurate and easy to use.
Great Lakes Dental Technologies, Ltd.
056-050
In Commercial Distribution

  • D7750560501 ()


  • Dental impression tray, reusable

Slap hammer - 07640187910520

A hammer with a mobile mass can be attached to the extraction clamp, as well as on the hook. It permits to give the necessary impact to extract the knee implants. This is a reusable device.
MPS Micro Precision Systems AG
T14585
In Commercial Distribution

  • 07640187910520 ()
T14585

  • Surgical mallet

FirstCheck HOME DRUG TEST - 06936983177689

REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177689 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

FirstCheck HOME DRUG TEST - 06936983177238

ABTDOAO16701A, 1T/kit, AMP500/COC150/FYL1/MET500/MOP300/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177238 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

NexScreen Cup - 00858984006071

THC, COC, AMP, MET, OPI with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-60500N-3A
Not in Commercial Distribution

  • 00858984006071 ()
C-60500N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 10722066007560

5 Panel One Step DOA Cup (5.1) - COC300 AMP1000 MET1000 THC50 OPI2000
BTNX Inc
D5.1-1VF
In Commercial Distribution

  • 00722066007563 ()
  • 10722066007560 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen (Private Label) - 564 - 00895330002967

Healgen (DrugConfirm) - 6 Panel Dip Test: BZO300/COC300/mAMP1000/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-564
In Commercial Distribution

  • 00895330002967 ()


  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Healgen (Private Label) - 264 - 00895330002813

Healgen (DrugConfirm) - 6 Panel Dip Card, CLIA AMP1000/BZO300/COC300/mAMP1000/MOP2000
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002813 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent

Healgen (Private Label) - 254 - 00895330002806

5 Panel Clia Cup COC/THC/OPI/AMP/mAMP
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-254
In Commercial Distribution

  • 00895330002806 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent

Healgen (Private Label) - 254 - 00895330002707

Healgen (DrugConfirm) - 5 Panel Dip Card - AMP1000/COC300/mAMP1000/MOP2000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-254
In Commercial Distribution

  • 00895330002707 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Healgen (Private Label) - 654 - 00895330002646

Healgen (DrugConfirm) - 5 Panel Dip Card - CLIA Waived - BZO300/COC300/mAMP1000/MOP2000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-654
In Commercial Distribution

  • 00895330002646 ()


  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Prime Screen - 00816862023985

Prime Screen® Multi-Panel Urine Test (5-Panel Card: AMP, COC, mAMP, OPI, THC), 5T/Bo
WONDFO USA CO., LTD.
DWDOA-254-5BX-A
In Commercial Distribution

  • 10816862023982 ()
  • 00816862023985 ()
  • 00816862023992 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Prime Screen - 00816862023671

5-Panel Card; 5 per box; AMP,BZO,COC,OPI,THC
WONDFO USA CO., LTD.
DWDOA-754-5BX-A
In Commercial Distribution

  • 10816862023678 ()
  • 00816862023671 ()
  • 00816862023688 ()
DWDOA-754-5BX-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405024018

5 panel CLIA Waived Urine Dip Card AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
ABTDOAW105402B
In Commercial Distribution

  • 30817405024019 ()
  • 00817405024018 ()
  • 10817405024015 ()
ABTDOAW105402B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405023509

5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK15701A
In Commercial Distribution

  • 30817405023500 ()
  • 00817405023509 ()
  • 10817405023506 ()
ABTDUAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405023493

5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
ABTDOAK15701A
In Commercial Distribution

  • 30817405023494 ()
  • 00817405023493 ()
  • 10817405023490 ()
ABTDOAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405023394

5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW15702B
In Commercial Distribution

  • 30817405023395 ()
  • 00817405023394 ()
  • 10817405023391 ()
ABTDUAW15702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405023332

7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50
Instant Technologies, Inc.
ABTDOAW17701A
In Commercial Distribution

  • 30817405023333 ()
  • 00817405023332 ()
  • 10817405023339 ()
ABTDOAW17701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405023295

5 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR, NI, OX, pH, S.G.)
Instant Technologies, Inc.
ABTDUAW15701A
In Commercial Distribution

  • 30817405023296 ()
  • 00817405023295 ()
  • 10817405023292 ()
ABTDUAW15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iScreen™ - 00817405023264

7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW17701A
In Commercial Distribution

  • 30817405023265 ()
  • 00817405023264 ()
  • 10817405023261 ()
ABTDUAW17701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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