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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 ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
ARK DIAGNOSTICS INC
5055-0001-01
In Commercial Distribution

  • 00812101030356 ()
5055-0001-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
ARK DIAGNOSTICS INC
5055-0001-00
In Commercial Distribution

  • 00812101030349 ()
5055-0001-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Input cable with ten leads AHA type and Clip connectors; Waiste Belt for mounting the wireless transmitter at Patient's hip.
NORAV MEDICAL LTD.
1200W Kit
In Commercial Distribution

  • 07290110255107 ()
1200W2-K-00-U-C10-17

  • Electrocardiography telemetric monitoring system transmitter
The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles in the 1st and 2nd metatarsal bones.
ALPHAMET LTD
V7
In Commercial Distribution

  • 07290017626192 ()
DG-9201

  • Orthopaedic implant aiming/guiding block attachment tool
MICHEL SUTURE CLIP, 22MM
HNM STAINLESS, LLC.
HNM-1-13-8022
In Commercial Distribution

  • 00842962110683 ()
HNM-1-13-8022

  • Surgical clip remover, reusable
MICHEL SUTURE CLIP, 18MM
HNM STAINLESS, LLC.
HNM-1-13-8018
In Commercial Distribution

  • 00842962110676 ()
HNM-1-13-8018

  • Surgical clip remover, reusable
MICHEL SUTURE CLIP, 16MM
HNM STAINLESS, LLC.
HNM-1-13-8016
In Commercial Distribution

  • 00842962110669 ()
HNM-1-13-8016

  • Surgical clip remover, reusable
MICHEL SUTURE CLIP, 11MM
HNM STAINLESS, LLC.
HNM-1-13-8011
In Commercial Distribution

  • 00842962110652 ()
HNM-1-13-8011

  • Surgical clip remover, reusable
MICHEL SUTURE CLIP, 7.5MM, 1000/PK
HNM STAINLESS, LLC.
HNM-1-13-8007
In Commercial Distribution

  • 00842962110645 ()
HNM-1-13-8007

  • Surgical clip remover, reusable
MICHEL SUTURE CLIP REMOVER FORCEPS, 4 3/4"
HNM STAINLESS, LLC.
HNM-1-13-7712
In Commercial Distribution

  • 00842962110638 ()
HNM-1-13-7712

  • Surgical clip remover, reusable
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