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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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Thinprep Imaging System - 15420045513716

Computer to operate the ThinPrep® Integrated Imager.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045513716 ()
CMP-01764

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507258

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507258 ()
CMP-01515

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504035

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504035 ()
CMP-01284

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045517585

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517585 ()
ASY-17964

  • Laboratory instrument/analyser application software IVD

Digital Refractor - 06971922130073

To check the refractive state of human eye.
Chongqing Yeasn Science & Technology Co.,Ltd.
YPA-2100
Not in Commercial Distribution

  • 06971922130073 ()


  • Phoropter, manual

BIOER MagaBio plus Virus RNA Purification Kit II - 06973843228594

For detail information,please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC87L1S
In Commercial Distribution

  • 06973843228594 ()


  • Nucleic acid extraction/isolation kit IVD

BIOER MagaBio plus Virus RNA Purification Kit II - 06973843228570

For detail information,please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC87M1S
In Commercial Distribution

  • 06973843228570 ()


  • Nucleic acid extraction/isolation kit IVD

Movement® - 10381780236955

The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89040PPT
In Commercial Distribution

  • M269TRL89040PPT1 ()
  • 10381780236955 ()

  • Size 40; .771 in L x .549 in W (head); .472 in L (stem)


  • Surgical implant template, reusable

Movement® - 10381780236948

The Proximal Phalanx Hemi Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89040PPH
In Commercial Distribution

  • M269TRL89040PPH1 ()
  • 10381780236948 ()

  • Size 40; .771 in L x .549 in W (head); .472 in L (stem)


  • Surgical implant template, reusable

Movement® - 10381780236924

The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89030PPT
In Commercial Distribution

  • M269TRL89030PPT1 ()
  • 10381780236924 ()

  • Size 30; .721 in L x .520 in W (head); .433 in L (stem)


  • Surgical implant template, reusable

Movement® - 10381780236917

The Proximal Phalanx Hemi Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89030PPH
In Commercial Distribution

  • M269TRL89030PPH1 ()
  • 10381780236917 ()

  • Size 30; .721 in L x .520 in W (head); .433 in L (stem)


  • Surgical implant template, reusable

Movement® - 10381780236894

The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89020PPT
In Commercial Distribution

  • M269TRL89020PPT1 ()
  • 10381780236894 ()

  • Size 20; .66 in L x .493 in W (head); .394 in L (stem)


  • Surgical implant template, reusable

Movement® - 10381780236887

The Proximal Phalanx Hemi Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89020PPH
In Commercial Distribution

  • M269TRL89020PPH1 ()
  • 10381780236887 ()

  • Size 20; .66 in L x .492 in W (head); .394 in L (stem)


  • Surgical implant template, reusable

Movement® - 10381780236863

The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89010PPT
In Commercial Distribution

  • M269TRL89010PPT1 ()
  • 10381780236863 ()

  • Size 10; .606 in L x .463 in W (head); .354 in L (stem)


  • Surgical implant template, reusable

Movement® - 10381780236856

The Proximal Phalanx Hemi Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89010PPH
In Commercial Distribution

  • M269TRL89010PPH1 ()
  • 10381780236856 ()

  • Size 10; .606 in L x .463 in W (head); .354 in L (stem)


  • Surgical implant template, reusable

Titan™ - 10381780236023

The Standard Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096009S
In Commercial Distribution

  • M269TRL096009S1 ()
  • 10381780236023 ()

  • Size +9S; .911 in H
TRL-0960-09S

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780236016

The Retentive Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096009R
In Commercial Distribution

  • M269TRL096009R1 ()
  • 10381780236016 ()

  • Size +9R; 1.031 in H
TRL-0960-09R

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780235972

The Standard Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096006S
In Commercial Distribution

  • M269TRL096006S1 ()
  • 10381780235972 ()

  • Size +6S; .793 in H
TRL-0960-06S

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780235965

The Retentive Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096006R
In Commercial Distribution

  • M269TRL096006R1 ()
  • 10381780235965 ()

  • Size +6R; .913 in H
TRL-0960-06R

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780235934

The Standard Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096003S
In Commercial Distribution

  • M269TRL096003S1 ()
  • 10381780235934 ()

  • Size +3S; .675 in H
TRL-0960-03S

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780235927

The Retentive Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096003R
In Commercial Distribution

  • M269TRL096003R1 ()
  • 10381780235927 ()

  • Size +3R; .795 in H
TRL-0960-03R

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780235910

The Eccentric Lipped Glenosphere Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096002EL
In Commercial Distribution

  • M269TRL096002EL1 ()
  • 10381780235910 ()

  • Size 2mm; 1.163 in H
TRL-0960-02EL

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780235880

The Standard Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096000S
In Commercial Distribution

  • M269TRL096000S1 ()
  • 10381780235880 ()

  • Size 0S; .557 in H
TRL-0960-00S

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780235873

The Retentive Poly Trial Liner is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL096000R
In Commercial Distribution

  • M269TRL096000R1 ()
  • 10381780235873 ()

  • Size 0R; .677 in H
TRL-0960-00R

  • Shoulder glenoid fossa prosthesis trial

Tips - D798EGTIPS1

To be used with the Get etchant in syringe as the dispensing tips for the Etchant.
RELIANCE ORTHODONTIC PRODUCTS INC
EGTIPS
Not in Commercial Distribution

  • D798EGTIPS1 ()
  • D798EGTIPS0 ()
EGTIPS

  • Dental material injection cannula, single-use

B-BOP® - 10381780043034

The drilling guide is used to guide the drills while preparing the holes for fixation screws.
NEWDEAL
189203ND
Not in Commercial Distribution

  • M248189203ND1 ()
  • 10381780043034 ()

  • 2.0mm diam. x 11mm length


  • Surgical drill guide, reusable

Titan™ - 10381780124368

The Definitive Fracture Body Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T95012008STD
In Commercial Distribution

  • M269TRL095012008STD1 ()
  • 10381780124368 ()

  • 08 Standard


  • Humeral body prosthesis trial

Titan™ - 10381780124351

The Definitive Fracture Body Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T95012008SML
In Commercial Distribution

  • M269TRL095012008SML1 ()
  • 10381780124351 ()

  • 08 Small


  • Humeral body prosthesis trial

Titan™ - 10381780124344

The Definitive Fracture Body Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T95012008LRG
In Commercial Distribution

  • M269TRL095012008LRG1 ()
  • 10381780124344 ()

  • 08 Large


  • Humeral body prosthesis trial

Integra® External Fixation System - 10381780125310

The round speed nut is used for quick temporary stabilization of the strut to the ring.
Ascension Orthopedics, Inc.
12224214
In Commercial Distribution

  • 10381780125310 ()

  • .87 in major dia x .560 in H
12224214

  • External orthopaedic fixation system, reusable
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