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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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Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-01A
In Commercial Distribution

  • M90107RD707301A1 ()
  • M90107RD707301A0 ()

  • Length: 75 Millimeter
07RD7073-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Integra® External Fixation System The universal bolt tubular wrench is used to tighten bolts and other parts in the external fixation system.
Ascension Orthopedics, Inc.
12224504
In Commercial Distribution

  • M269122245041 ()
  • 10381780248071 ()

  • 168.96 mm L; 10.1 mm opening
12224504

  • External orthopaedic fixation system, reusable
CAPTURE™ High Torque Screw System The trocar pin sleeve is used during guide pin placement in the Capture high torque screw system.
Ascension Orthopedics, Inc.
TPS-5000-501-070
In Commercial Distribution

  • M269TPS50005010701 ()
  • 10381780247715 ()

  • 91.03 mm L
PS5000501070

  • Surgical drill guide, reusable
Surgical Direct TCI Endoscope: ..Sapphire Lens System, Made In Germany, Distal Tip 8fr. Graduated, 43cm Working Length, 5fr. Channel, 2 Irrigation Ports, Autoclavable
Surgical Direct, Inc.
SD80009
In Commercial Distribution

  • B382SD800090 ()

  • Length: 43 Centimeter
  • Catheter Gauge: 8 French
SD80009

  • Endoscope sheath, reusable
Cadence Talar Reamer is placed down through the holes in the Talar Chamfer Reamer Guide and ream the anterior surface of the talus.
Ascension Orthopedics, Inc.
10204057
In Commercial Distribution

  • M268102040571 ()
  • 10381780240419 ()

  • .325in L diame177in diameter Thread
10204057

  • Bone-resection orthopaedic reamer, reusable
AO Hex Driver is used in conjunction with the Screwdriver Handle to assemble an AO Hex Driver and used to tighten locking screws
Ascension Orthopedics, Inc.
10204146
In Commercial Distribution

  • M268102041461 ()
  • 10381780240716 ()

  • 2.7in L x .177in diameter
10204146

  • Surgical screwdriver, reusable
Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. 20g Maximum Cure Sealant Resin B
RELIANCE ORTHODONTIC PRODUCTS INC
MC20B
In Commercial Distribution

  • D798MC20B0 ()
MC20B

  • Orthodontic bracket adhesive
Excel is intended for use as an orthodontic bonding adhesive for appliances. This is a12g Excel Regular Adhesive paste B in a jar.
RELIANCE ORTHODONTIC PRODUCTS INC
ERJB
In Commercial Distribution

  • D798ERJB0 ()
ERJB

  • Orthodontic bracket adhesive
The Reliance Button Hook Aligner Attachments are intended for use in securing a Class II elastic to a thermoplastic aligner or enamel surface.
RELIANCE ORTHODONTIC PRODUCTS INC
ABUT
In Commercial Distribution

  • D798ABUT0 ()
ABUT

  • Dental mould
Flowable Microhybrid Kit includes 11 (3 g) syringes of Flowable Microhybrid, and 50 tips (25 - 18 gauge, 25 - 19 gauge) in the Tray.
COSMEDENT, INC.
701005
In Commercial Distribution

  • D7797010053 ()
701005

  • Dental composite resin
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