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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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Biomeme RNA Process Control (RPC) Kiit - 00810096640079

RNA Process Control for Biomeme's SARS-CoV-2 assay form factors (Go-Strips, Go-Plate, or Bulk Vials)
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640076 ()
  • 00810096640079 ()
3000627

  • Exogenous DNA/RNA internal control IVD, kit

Biomeme Void Filling Caps - 00810096640062

Void Filling Caps for sealing Biomeme PCR Go-Strips during thermocycling. Caps only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640069 ()
  • 00810096640062 ()
3000520

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Biomeme SARS-CoV-2 Go-Strips - 00810096640055

Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640052 ()
  • 00810096640055 ()
3000633

  • Nucleic acid amplification mastermix reagent IVD

Biomeme SARS-CoV-2 Go-Strips Kit - 00810096640048

Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit and Void Filling Caps.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640045 ()
  • 00810096640048 ()
3000555

  • Nucleic acid amplification mastermix kit IVD

Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 - 00810096640031

RNA Extraction Kit containing cartridges, syringes, and binding column tips.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640038 ()
  • 00810096640031 ()
3000536

  • Nucleic acid extraction/isolation kit IVD

Curaplex - 00810094576615

Curaplex Opioid Overdose Kit (2 Dose, Face Shield, Yellow Case)
BOUND TREE MEDICAL, LLC
SRxOD2SY-24-KIT
In Commercial Distribution

  • 00810094576615 ()
SRxOD2SY-24-KIT

  • First aid kit, medicated

INDALJIMTM - 07506561200130

No Description
Indaljim, S.A. de C.V.
C3C-01
In Commercial Distribution

  • 07506561200130 ()


  • Public face mask, single-use

The Tether™ - 00887868227455

CORD TENSIONER
ZIMMER BIOMET INC
230H6003
In Commercial Distribution

  • 00887868227455 ()


  • General internal orthopaedic fixation system implantation kit

The Tether™ - 00887868227448

COUNTER TENSIONER
ZIMMER BIOMET INC
230H6002
In Commercial Distribution

  • 00887868227448 ()


  • General internal orthopaedic fixation system implantation kit

The Tether™ - 00887868227387

ANCHOR INSERTER INNER DTS
ZIMMER BIOMET INC
230H2002
In Commercial Distribution

  • 00887868227387 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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