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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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Link Embrace Shoulder System - Instruments - 04026575281145

Shoulder revision prosthesis trial - LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG
643-836/20
In Commercial Distribution

  • 04026575281145 ()


  • Shoulder revision prosthesis trial

Endo-Model Knee System - Instruments - 04026575306312

Knee femur prosthesis trial - General Instrument
WALDEMAR LINK GmbH & Co. KG
151-050/20
In Commercial Distribution

  • 04026575306312 ()


  • Knee femur prosthesis trial, reusable

LinkSymphoKnee - Instruments - 04026575305933

Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-151/20
In Commercial Distribution

  • 04026575305933 ()


  • Knee femur prosthesis trial, reusable

LinkSymphoKnee - Instruments - 04026575304639

Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-105/20
In Commercial Distribution

  • 04026575304639 ()


  • Knee femur prosthesis trial, reusable

LINK Instruments - Chisel, bone curette, raspatory, rongeur - 04026575303878

Orthopaedic prosthesis instrument, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
65-1702/20
In Commercial Distribution

  • 04026575303878 ()


  • Orthopaedic chisel blade

Endo-Model Knee System - Instruments - 04026575303021

Orthopaedic implant aiming/guiding block, reusable - Endo Model Knee System
WALDEMAR LINK GmbH & Co. KG
151-102/20
In Commercial Distribution

  • 04026575303021 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Endo-Model Knee System - Instruments - 04026575302765

Orthopaedic implant aiming/guiding block, reusable - Endo Model Knee System
WALDEMAR LINK GmbH & Co. KG
151-104/20
In Commercial Distribution

  • 04026575302765 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Universal seat cover and backrest cover Shell Cover - 08056646505883

Universal seat cover and backrest cover Shell Cover
OMNIA SRL
20.O0105.00
In Commercial Distribution

  • 08056646505890 ()
  • 08056646505883 ()


  • Medical equipment/instrument drape, single-use

Omnicover - 08056646505722

Round waterproof headrest cover Ø 22 cm with elastic Shell Cover
OMNIA SRL
20.O0010.00
In Commercial Distribution

  • 08056646505739 ()
  • 08056646505722 ()


  • Medical equipment/instrument drape, single-use

DVT Sleeve - 00816317023140

Flowtron large sequential calf garment- fits up to 23 in. calf circumference.
RENU MEDICAL, INC
RM-TRP 20
In Commercial Distribution

  • 10816317023147 ()
  • 00816317023140 ()


  • Multi-chamber venous compression system garment, reprocessed

Movement® - 10381780246695

Movement® Great Toe System Proximal Phalanx Surface Reamer Sz. 10/2 The Movement Great Toe proximal phalanx surface reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
PSR-890-10/20
In Commercial Distribution

  • M269PSR89010201 ()
  • 10381780246695 ()

  • Size 10/20; 3.12 in L x .720 in dia
PSR8901020

  • Bone-resection orthopaedic reamer, reusable

Movement® - 10381780246268

Movement® Great Toe System Metatarsal Surface Reamer Sz. 10/20 The Movement Great Toe metatarsal surface reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
MSR-890-10/20
In Commercial Distribution

  • M269MSR89010201 ()
  • 10381780246268 ()

  • Size 10/20; 3.20 in L
MSR8901020

  • Bone-resection orthopaedic reamer, reusable

XPERT20 - B619X20Q9

specimen x-ray system
Kubtec
XPERT 20
In Commercial Distribution

  • B619X20Q9 ()


  • Tissue specimen x-ray system IVD

KUBTEC - B619X200

specimen x-ray system
Kubtec
XPERT 20
In Commercial Distribution

  • B619X200 ()


  • Tissue specimen x-ray system IVD

DRIVER HANDPIECE IMP. SLIM 20MM - 07899995293428

DRIVER HANDPIECE IMP. SLIM 20MM
Sin Sistema de Implante Nacional S/A
CTS 20
In Commercial Distribution

  • 07899995293428 ()


  • Surgical screwdriver, reusable

C & B FORMULA - D772ATI400404200

C & B FORMULA 4 OZ SHADE 20
AMERICAN TOOTH INDUSTRIES
070-40-0404/20
In Commercial Distribution

  • D772ATI400404200 ()


  • Temporary dental crown/bridge resin

C & B FORMULA - D772ATI400401200

C & B FORMULA 1 OZ SHADE 20
AMERICAN TOOTH INDUSTRIES
070-40-0401/20
In Commercial Distribution

  • D772ATI400401200 ()


  • Temporary dental crown/bridge resin

C & B FORMULA - D772ATI400420200

C & B FORMULA 1LB SHADE 20
AMERICAN TOOTH INDUSTRIES
070-40-0420/20
In Commercial Distribution

  • D772ATI400420200 ()


  • Temporary dental crown/bridge resin

DRIVER HANDPIECE IMP. COMPACT 20MM - 07899995278807

DRIVER HANDPIECE IMP. COMPACT 20MM
Sin Sistema de Implante Nacional S/A
CTC 20
In Commercial Distribution

  • 07899995278807 ()


  • Surgical screwdriver, reusable

DRILL HELICAL Ø2,0MM GUIDED - 07899995276711

DRILL HELICAL Ø2,0MM GUIDED
Sin Sistema de Implante Nacional S/A
FHG 20
In Commercial Distribution

  • 07899995276711 ()


  • Surgical screwdriver, reusable
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