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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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CannuLink - 00846832036028

CANNULATED DRILL BIT
TORNIER, INC.
IFS-072-20-C
In Commercial Distribution

  • 00846832036028 ()

  • Outer Diameter: 2 Millimeter
IFS-072-20-C

  • Drilling power tool attachment, basic

MaxTorque - 00846832034659

CANNULATED DRILL BIT
TORNIER, INC.
HCS-072-20
In Commercial Distribution

  • 00846832034659 ()

  • Outer Diameter: 2 Millimeter
HCS-072-20

  • Drilling power tool attachment, basic

MaxLock Extreme™ - 00846832028801

OrthoLink™ Wedge
TORNIER, INC.
COW-003-02
Not in Commercial Distribution

  • 00846832028801 ()

  • Outer Diameter: 2 Millimeter
COW-003-02

  • Orthopaedic fixation plate, non-bioabsorbable

OrthoLink™ - 00846832028726

Wedge Plate
TORNIER, INC.
COW-002-02
Not in Commercial Distribution

  • 00846832028726 ()

  • Outer Diameter: 2 Millimeter
COW-002-02

  • Orthopaedic fixation plate, non-bioabsorbable

CalcLock - 00846832028016

STEINMAN PIN
TORNIER, INC.
CAT-040-20
In Commercial Distribution

  • 00846832028016 ()

  • Outer Diameter: 2 Millimeter
CAT-040-20

  • Orthopaedic implant calibration pin

MaxLock - 00846832046287

LAG DRILL BIT
TORNIER, INC.
MXM-072-20
In Commercial Distribution

  • 00846832046287 ()

  • Outer Diameter: 2 Millimeter
MXM-072-20

  • Drilling power tool attachment, basic

MaxLock Extreme™ - 00846832041701

OrthoLink™ Medial Wedge Osteotomy Plate
TORNIER, INC.
MOW-003-2
Not in Commercial Distribution

  • 00846832041701 ()

  • Outer Diameter: 2 Millimeter
MOW-003-2

  • Orthopaedic fixation plate, non-bioabsorbable

APOZA - 04719883751362

Light Guide 8mm to 2mm. Accessories for APOZA LED Light Curing Unit
APOZA ENTERPRISE CO., LTD.
LIGHT GUIDE-8mm to 2mm
In Commercial Distribution

  • 04719883751362 ()

  • Outer Diameter: 2 Millimeter


  • Dental/surgical polymerization lamp

Myron L® Company - 00857744006221

An accessory for the D-6 Dialysate Meter™. A hard case, foam-lined protective carrying case. Contains 1 (one) each 2 oz bottle of 14.0 millimohs, NaCl Standard Solution (P/N NACL-14.02OZ; UDI# 00857744006108). This is the only listed component included this item. The D-6 Dialysate Meter™ is packaged separately. NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
PortaKit for D-6 Digital Dialysate Meter
In Commercial Distribution

  • 00857744006221 ()

  • Total Volume: 2 Fluid Ounce
PKD

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006108

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, 2 Ounces
In Commercial Distribution

  • 00857744006108 ()

  • Total Volume: 2 Fluid Ounce
NACL-14.02OZ

  • Haemodialysis conductivity standard solution
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