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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4MM X 20MM SELF TAPPING HALF PIN
ORTHOPAEDIC IMPLANT COMPANY, THE
STHP-0420
In Commercial Distribution

  • 10811998038398 ()

  • Outer Diameter: 4.0 Millimeter
  • Thread Length: 20 Millimeter
  • Length: 150 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
5MM X 65MM BLUNT TIPPED HALF PIN
ORTHOPAEDIC IMPLANT COMPANY, THE
BLHP-0565L
In Commercial Distribution

  • 10811998038312 ()

  • Outer Diameter: 5.0 Millimeter
  • Thread Length: 65 Millimeter
  • Length: 200 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
5MM X 55MM BLUNT TIPPED HALF PIN
ORTHOPAEDIC IMPLANT COMPANY, THE
BLHP-0555L
In Commercial Distribution

  • 10811998038305 ()

  • Length: 200 Millimeter
  • Thread Length: 55 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
5MM X 45MM BLUNT TIPPED HALF PIN
ORTHOPAEDIC IMPLANT COMPANY, THE
BLHP-0545M
In Commercial Distribution

  • 10811998038299 ()

  • Outer Diameter: 5.0 Millimeter
  • Thread Length: 45 Millimeter
  • Length: 150 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
5MM X 35MM BLUNT TIPPED HALF PIN
ORTHOPAEDIC IMPLANT COMPANY, THE
BLHP-0535M
In Commercial Distribution

  • 10811998038282 ()

  • Length: 150 Millimeter
  • Thread Length: 35 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
4MM X 30MM BLUNT TIPPED HALF PIN
ORTHOPAEDIC IMPLANT COMPANY, THE
BLHP-0430
In Commercial Distribution

  • 10811998038275 ()

  • Outer Diameter: 4.0 Millimeter
  • Thread Length: 30 Millimeter
  • Length: 150 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
4MM X 20MM BLUNT TIPPED HALF PIN
ORTHOPAEDIC IMPLANT COMPANY, THE
BLHP-0420
In Commercial Distribution

  • 10811998038268 ()

  • Length: 150 Millimeter
  • Thread Length: 20 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
Gel Part B Catalyst - 25g
In Commercial Distribution

  • 05060483016283 ()
M510(25)

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
Gel Part B Catalyst - 50g
In Commercial Distribution

  • 05060483016276 ()
M510(50)

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
M511 Trial Kit
In Commercial Distribution

  • 05060483016184 ()
M73

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
Silicone Rubber – Part A (250g)
In Commercial Distribution

  • 05060483016177 ()
M511(250g)

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
Gel Part B Catalyst – 100g
In Commercial Distribution

  • 05060483016108 ()
M510(100)

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
TechSil 25 – 1kg
In Commercial Distribution

  • 05060483012162 ()
S25(1kg)

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
TechSil 25 – 500g
In Commercial Distribution

  • 05060483012155 ()
S25(500g)

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
Prosthetics Starter Kit
In Commercial Distribution

  • 05060483012148 ()
M72

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
Silicone Rubber – 1kg
In Commercial Distribution

  • 05060483012094 ()
M511(1kg)

  • Dental appliance fabrication material, resin
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
Silicone Rubber – 500g
In Commercial Distribution

  • 05060483012087 ()
M511(500g)

  • Dental appliance fabrication material, resin
LOCATOR R-Tx Abutment for 3.4mm External Hex Implant, Biomet 3i, 1mm Cuff
Zest Anchors, LLC
30305-06
In Commercial Distribution

  • 00840481114144 ()

  • Length: 6 Millimeter
30305-06

  • Dental implant suprastructure, permanent, preformed
LOCATOR R-Tx Abutment for 3.4mm External Hex Implant, Biomet 3i, 5mm Cuff
Zest Anchors, LLC
30305-05
In Commercial Distribution

  • 00840481114137 ()

  • Length: 5 Millimeter
30305-05

  • Dental implant suprastructure, permanent, preformed
LOCATOR R-Tx Abutment for 3.4mm External Hex Implant, Biomet 3i, 4mm Cuff
Zest Anchors, LLC
30305-04
In Commercial Distribution

  • 00840481114120 ()

  • Length: 4 Millimeter
30305-04

  • Dental implant suprastructure, permanent, preformed
LOCATOR R-Tx Abutment for 3.4mm External Hex Implant, Biomet 3i, 1mm Cuff
Zest Anchors, LLC
30305-01
In Commercial Distribution

  • 00840481114090 ()

  • Length: 1 Millimeter
30305-01

  • Dental implant suprastructure, permanent, preformed
LOCATOR R-Tx Abutment for 3.4mm External Hex Implant, Biomet 3i, 3mm Cuff
Zest Anchors, LLC
30305-03
In Commercial Distribution

  • 00840481114113 ()

  • Length: 3 Millimeter
30305-03

  • Dental implant suprastructure, permanent, preformed
LOCATOR R-Tx Abutment for 3.4mm External Hex Implant, Biomet 3i, 2mm Cuff
Zest Anchors, LLC
30305-02
In Commercial Distribution

  • 00840481114106 ()

  • Length: 2 Millimeter
30305-02

  • Dental implant suprastructure, permanent, preformed
Titanium Base
MEDENTiKA GmbH
I 1120
In Commercial Distribution

  • EMKAI1120 ()

  • Compatible with implant system: Biomet 3i External Hex Implant; 5,0
  • Height: 5.5 Millimeter


  • Dental implant suprastructure, permanent, preformed
Titanium Base
MEDENTiKA GmbH
I 1110
In Commercial Distribution

  • EMKAI1110 ()

  • Height: 5.5 Millimeter
  • Compatible with implant system: Biomet 3i External Hex Implant; 4,1


  • Dental implant suprastructure, permanent, preformed
Titanium Base
MEDENTiKA GmbH
I 1100
In Commercial Distribution

  • EMKAI1100 ()

  • Compatible with implant system: Biomet 3i External Hex Implant; 3,4
  • Height: 5.5 Millimeter


  • Dental implant suprastructure, permanent, preformed
Titanium Base
MEDENTiKA GmbH
I 820
In Commercial Distribution

  • EMKAI820 ()

  • Compatible with implant system: Biomet 3i External Hex Implant; 5,0
  • Height: 4 Millimeter


  • Dental implant suprastructure, permanent, preformed
Titanium Base
MEDENTiKA GmbH
I 810
In Commercial Distribution

  • EMKAI810 ()

  • Height: 4 Millimeter
  • Compatible with implant system: Biomet 3i External Hex Implant; 4,1


  • Dental implant suprastructure, permanent, preformed
Titanium Base
MEDENTiKA GmbH
I 800
In Commercial Distribution

  • EMKAI800 ()

  • Height: 4 Millimeter
  • Compatible with implant system: Biomet 3i External Hex Implant; 3,4


  • Dental implant suprastructure, permanent, preformed
Integra® External Fixation System The punch is used for the half pin drill guide in the external fixation system.
Ascension Orthopedics, Inc.
12225020002
In Commercial Distribution

  • M269122250200021 ()
  • 10381780248187 ()

  • 5.245 in L x .176 in dia
12225020002

  • Surgical drill guide, reusable
Integra® External Fixation System This handle is used for the half pin drill guide in the external fixation system.
Ascension Orthopedics, Inc.
12225020001
In Commercial Distribution

  • M269122250200011 ()
  • 10381780248170 ()

  • 4.388 in L x .235 in dia cannula; 3.036 in L handle
12225020001

  • Surgical instrument handle, non-torque-limiting
Integra® External Fixation System The wire cutter is a tool used to cut wire with the External Fixation System.
Ascension Orthopedics, Inc.
12224508
In Commercial Distribution

  • M269122245081 ()
  • 10381780248101 ()

  • 222.7 mm L
12224508

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The wire bender is a tool used to bend wire with the External Fixation System.
Ascension Orthopedics, Inc.
12224507
In Commercial Distribution

  • M269122245071 ()
  • 10381780248095 ()

  • 187 mm L
12224507

  • Manual orthopaedic bender, reusable
Integra® External Fixation System The box wrench combination h is used to tighten parts in the external fixation system.
Ascension Orthopedics, Inc.
12224502
In Commercial Distribution

  • M269122245021 ()
  • 10381780248064 ()

  • 178 mm L; 13.0 mm openings
12224502

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The box wrench combination h is used to tighten parts in the external fixation system.
Ascension Orthopedics, Inc.
12224501
In Commercial Distribution

  • M269122245011 ()
  • 10381780248057 ()

  • 145 mm L; 10.0 mm openings
12224501

  • External orthopaedic fixation system, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0611
In Commercial Distribution

  • 00848665002423 ()


  • Orthopaedic implantation sleeve, reusable
Unit; External inputs cable for Task Force® Monitor; 2,5m
CNSystems Medizintechnik GmbH
X
Not in Commercial Distribution

  • 09120073931818 ()
HEKA3141

  • General-purpose multi-parameter bedside monitor
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1153
In Commercial Distribution

  • 00848665005462 ()


  • General external orthopaedic fixation system implantation kit, reusable
ASSY PEDIATRIC PADDLE,MULTI LANGUAGE, 3RD EDT
PHYSIO-CONTROL, INC.
11133
In Commercial Distribution

  • 00883873761441 ()
11133-000008

  • External defibrillation electrode, adult, reusable
No Description
Synapse Biomedical, Inc.
23-0001
In Commercial Distribution

  • 00852184003502 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator
External remote controller - for use with the FREEDOM residual limb lengthening system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
P003
In Commercial Distribution

  • 00856719002220 ()

  • tool/instrument
EAD-P1-020

  • Distraction implant adjustment remote control
External remote controller - for use with the MAGEC spinal bracing and distraction system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
P003
In Commercial Distribution

  • 00856719002107 ()

  • tool/instrument
EAD-P1-000

  • Distraction implant adjustment remote control
Lock-Attach Dental Implant Abutment
FUSION DENTAL IMPLANTS LLC
4.1 Lock-Attach Abutment
In Commercial Distribution

  • D985HE419060 ()
HE41906

  • Basket endosteal dental implant, two-piece
Lock-Attach Dental Implant Abutment
FUSION DENTAL IMPLANTS LLC
4.1 Lock-Attach Abutment
In Commercial Distribution

  • D985HE419050 ()
HE41905

  • Basket endosteal dental implant, two-piece
Lock-Attach Dental Implant Abutment
FUSION DENTAL IMPLANTS LLC
4.1 Lock-Attach Abutment
In Commercial Distribution

  • D985HE419040 ()
HE41904

  • Basket endosteal dental implant, two-piece
Lock-Attach Dental Implant Abutment
FUSION DENTAL IMPLANTS LLC
4.1 Lock-Attach Abutment
In Commercial Distribution

  • D985HE419030 ()
HE41903

  • Basket endosteal dental implant, two-piece
Lock-Attach Dental Implant Abutment
FUSION DENTAL IMPLANTS LLC
4.1 Lock-Attach Abutment
In Commercial Distribution

  • D985HE419020 ()
HE41902

  • Basket endosteal dental implant, two-piece
Lock-Attach Dental Implant Abutment
FUSION DENTAL IMPLANTS LLC
4.1 Lock-Attach Abutment
In Commercial Distribution

  • D985HE419010 ()
HE41901

  • Basket endosteal dental implant, two-piece
Provisional Dental Implant Abutment. non engaging
FUSION DENTAL IMPLANTS LLC
4.1 Non Eng Temp Abutment
In Commercial Distribution

  • D985HE416100 ()
HE41610

  • Basket endosteal dental implant, two-piece
Provisional Dental Implant Abutment
FUSION DENTAL IMPLANTS LLC
4.1 Temp Abutment
In Commercial Distribution

  • D985HE416000 ()
HE41600

  • Basket endosteal dental implant, two-piece
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