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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Personalized Case and Tray 1 - Extras - Tray 2
ORTHOPEDIATRICS CORP.
03-1600-2009
In Commercial Distribution

  • 00841132185261 ()
03-1600-2009

  • Instrument tray, reusable
Personalized Case and Tray 1 - Extras - Tray 1
ORTHOPEDIATRICS CORP.
03-1600-2008
In Commercial Distribution

  • 00841132185254 ()
03-1600-2008

  • Instrument tray, reusable
ILIO SACRAL CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200558
In Commercial Distribution

  • 03613720211747 ()


  • Surgical instrument/implant rack
ILIAC FIXATION CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200557
In Commercial Distribution

  • 03613720211730 ()


  • Surgical instrument/implant rack
SPECIAL CONNECTORS CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200556
Not in Commercial Distribution

  • 03613720211723 ()


  • Surgical instrument/implant rack
EXTRA SCREW CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200548
In Commercial Distribution

  • 03613720211662 ()


  • Instrument tray, reusable
OFFSET SCREW CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200547
Not in Commercial Distribution

  • 03613720211655 ()


  • Surgical instrument/implant rack
7.5 SCREW CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200546
In Commercial Distribution

  • 03613720211648 ()


  • Instrument tray, reusable
6.5 SCREW CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200545
In Commercial Distribution

  • 03613720211631 ()


  • Instrument tray, reusable
5.5 SCREW CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200544
In Commercial Distribution

  • 03613720211624 ()


  • Instrument tray, reusable
4.5 SCREW CADDY FOR PASS LP IMPLANTS CASE
MEDICREA INTERNATIONAL
A02200543
In Commercial Distribution

  • 03613720211617 ()


  • Instrument tray, reusable
Valeo TL/PL Prep Case 1 Tray 1
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555910000020 ()
91.000.0020

  • Instrument tray, reusable
Miniplating System, Sterilization Case, Size 300x300x100 mm. Empty
FAICO MEDICAL LLC
F2.0-998-350
Not in Commercial Distribution

  • 00840192715807 ()


  • General internal orthopaedic fixation system implantation kit
Mediumplating System, Sterilization Case, Size 300x300x100 mm. Empty
FAICO MEDICAL LLC
F1.5-998-240
Not in Commercial Distribution

  • 00840192715166 ()


  • General internal orthopaedic fixation system implantation kit
Gen II Instrument Case 1 Upper Tier Tray
ORTHOPEDIATRICS CORP.
01-1501-0524
In Commercial Distribution

  • 00840194417334 ()
01-1501-0524

  • Instrument tray, reusable
Gen II Instrument Case 2 Upper Tier Tray
ORTHOPEDIATRICS CORP.
01-1501-0520
In Commercial Distribution

  • 00840194405980 ()
01-1501-0520

  • Instrument tray, reusable
Lid, Phantom Plus PLIF, TLIF System Case 2
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000103 ()
31-6000-103

  • Instrument tray, reusable
LOWER CASE, DJO EMPOWR COMPLETE PATELLA TOOL KIT
Encore Medical, L.P.
800-99-127
In Commercial Distribution

  • 00190446256014 ()


  • Surgical implant template, reusable
Base, Phantom Plus PLIF, TLIF System Case 1
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000404 ()
31-6000-404

  • Instrument tray, reusable
Base, Phantom Plus PLIF, TLIF System Case 2
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000303 ()
31-6000-303

  • Instrument tray, reusable
Lid, Phantom Plus PLIF, TLIF System Case 1
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000104 ()
31-6000-104

  • Instrument tray, reusable
UPPER CASE, DJO EMPOWR COMPLETE PATELLA TOOL KIT
Encore Medical, L.P.
800-99-126
In Commercial Distribution

  • 00190446256007 ()


  • Surgical implant template, reusable
LOWER CASE, EMPOWR CR KNEE FEM-TRIALS, CORE, RIGHT
Encore Medical, L.P.
800-99-123
In Commercial Distribution

  • 00190446243878 ()


  • Instrument tray, reusable
LOWER CASE, EMPOWR CR KNEE FEM-TRIALS, CORE, LEFT
Encore Medical, L.P.
800-99-121
In Commercial Distribution

  • 00190446243854 ()


  • Instrument tray, reusable
UPPER CASE, EMPOWR CR KNEE FEM-TRIALS, CORE, LEFT
Encore Medical, L.P.
800-99-120
In Commercial Distribution

  • 00190446243847 ()


  • Instrument tray, reusable
5.5/6.0 Response Power Final Tighten Case - Base
ORTHOPEDIATRICS CORP.
03-1300-0150
In Commercial Distribution

  • 00840194428064 ()
03-1300-0150

  • Instrument tray, reusable
5.5/6.0 Response Power Final Tighten Case - Lid
ORTHOPEDIATRICS CORP.
03-1300-0155
In Commercial Distribution

  • 00840194428057 ()
03-1300-0155

  • Instrument tray, reusable
4.5/5.0 Response Power Final Tighten Case - Base
ORTHOPEDIATRICS CORP.
03-1600-0150
In Commercial Distribution

  • 00840194428040 ()
03-1600-0150

  • Instrument tray, reusable
4.5/5.0 Response Power Final Tighten Case - Lid
ORTHOPEDIATRICS CORP.
03-1600-0155
In Commercial Distribution

  • 00840194428033 ()
03-1600-0155

  • Instrument tray, reusable
GRAPHIC CASE WITH LID RIA 2 INSTRUMENT SET
Synthes GmbH
60.404.000
In Commercial Distribution

  • 07612334142573 ()
  • 10886982280718 ()
60404000

  • Surgical instrument/implant rack
Evolve Tissue Culture Bag, 120ml, case of 20
ORIGEN BIOMEDICAL, INC.
EV120
Not in Commercial Distribution

  • 10816203021592 ()
  • 20816203021599 ()


  • Blood/tissue storage/culture container
Protective Cap for female luer, case of 50
ORIGEN BIOMEDICAL, INC.
PC2-B
Not in Commercial Distribution

  • 20816203021704 ()
  • 10816203021707 ()


  • Blood transfer set
INSTRUMENT CASE, SS, 24CM X 26CM X 2.5CM
BLACK & BLACK SURGICAL, INC.
B3C-4011
In Commercial Distribution

  • 00840329812294 ()
B3C-4011

  • Instrument tray, reusable
Stress and Holter Electrode 60/POUCH, 600 /CASE
GRAPHIC CONTROLS ACQUISITION CORP
LMC 404
In Commercial Distribution

  • 20813150022464 ()
  • 10813150022467 ()
  • 00813150022460 ()
LMC 404

  • Electrocardiographic electrode, single-use
100/pouch, 1,000 per box, 4000 per case
GRAPHIC CONTROLS ACQUISITION CORP
E-5253
Not in Commercial Distribution

  • 10813150022245 ()
  • 00813150022248 ()
E-5253

  • Electrocardiographic electrode, single-use
Packed for: Altura Medical 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
KIT-ALT2
In Commercial Distribution

  • 10813150022016 ()
  • 00813150022019 ()
KIT-ALT2

  • Electrocardiographic long-term ambulatory recording support kit
Packed for: Med Monitoring-LLC 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
KIT-MED37A
In Commercial Distribution

  • 10813150021903 ()
  • 00813150021906 ()
KIT-MED37A

  • Electrocardiographic long-term ambulatory recording support kit
Packed for: Med Monitoring 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
K-MED CD7AA
Not in Commercial Distribution

  • 10813150021842 ()
  • 00813150021845 ()
K-MED CD7AA

  • Electrocardiographic long-term ambulatory recording support kit
Packed for J.L. Marketing 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
K-JLM3
In Commercial Distribution

  • 10813150021835 ()
  • 00813150021838 ()
K-JLM3

  • Electrocardiographic long-term ambulatory recording support kit
Packed for J.L. Marketing 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
K-JLM2
In Commercial Distribution

  • 10813150021828 ()
  • 00813150021821 ()
K-JLM2

  • Electrocardiographic long-term ambulatory recording support kit
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