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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Case ASM, IMP, Rod, CoCr HY, PB, 5.5
Xtant Medical Holdings, Inc.
1509-200200
In Commercial Distribution

  • 00840311252190 ()


  • Instrument tray, reusable
ZEUS®-A INSTRUMENT AND IMPLANT TRAY CASE
SPINAL ELEMENTS
A-TR
Not in Commercial Distribution

  • 00840916146221 ()


  • Device sterilization/disinfection container, reusable
ZEUS®-C INSTRUMENT AND IMPLANT TRAY CASE
SPINAL ELEMENTS
C-TR
Not in Commercial Distribution

  • 00840916145651 ()


  • Device sterilization/disinfection container, reusable
4.5mm Locking Compression Femur Plate Case Inner Tray
ORTHOPEDIATRICS CORP.
01-1065-4510
In Commercial Distribution

  • 00841132151181 ()
01-1065-4510

  • Orthopaedic surgical procedure kit, non-medicated, reusable
3.5mm Locking Compression Femur Plate Case Inner Tray
ORTHOPEDIATRICS CORP.
01-1065-4030
In Commercial Distribution

  • 00841132151136 ()
01-1065-4030

  • Surgical instrument handle, non-torque-limiting
SL LMBR RET SYS INSTRUMENT CASE TOP TRAY
CAREFUSION 2200, INC
Y-0170-11
Not in Commercial Distribution

  • 10885403242137 ()
Y-0170-11

  • Device sterilization/disinfection container, reusable
Personalized Case and Tray 1 - Extras - Tray 3
ORTHOPEDIATRICS CORP.
03-1600-2010
In Commercial Distribution

  • 00841132185278 ()
03-1600-2010

  • Instrument tray, reusable
PLEO IMPLANT/INSTRUMENT SET II (IMPLANT, INSTRUMENT, & CASE)
ORTHOPEDIATRICS CORP.
01-1050-6102
In Commercial Distribution

  • 00841132134306 ()
01-1050-6102

  • Orthopaedic surgical procedure kit, non-medicated, reusable
PLEO IMPLANT/INSTRUMENT SET I (IMPLANT, INSTRUMENT, & CASE)
ORTHOPEDIATRICS CORP.
01-1050-6100
In Commercial Distribution

  • 00841132134290 ()
01-1050-6100

  • Orthopaedic surgical procedure kit, non-medicated, reusable
4.5MM IMPLANT/INSTRUMENT SET I (IMPLANT, INSTRUMENT, & CASE)
ORTHOPEDIATRICS CORP.
01-1050-4100
In Commercial Distribution

  • 00841132134269 ()
01-1050-4100

  • Orthopaedic surgical procedure kit, non-medicated, reusable
3.5MM IMPLANT/INSTRUMENT SET I (IMPLANT, INSTRUMENT, & CASE)
ORTHOPEDIATRICS CORP.
01-1050-3100
In Commercial Distribution

  • 00841132134184 ()
01-1050-3100

  • Orthopaedic surgical procedure kit, non-medicated, reusable
ORTHOPEDIATRICS CASE COMPLETE MASTER LABEL WITH CE MARK
ORTHOPEDIATRICS CORP.
01-0999-104
In Commercial Distribution

  • 00841132133194 ()
01-0999-104

  • Orthopaedic surgical procedure kit, non-medicated, reusable
JET-X AUXILLARY INSTRUMENT MODULE STERILIZATION CASE WITH LID
Smith & Nephew, Inc.
71067354
In Commercial Distribution

  • 03596010608086 ()
71067354

  • Device sterilization/disinfection container, reusable
JET-X HALF PIN MODULE STERILIZATION CASE WITH LID
Smith & Nephew, Inc.
71067360
In Commercial Distribution

  • 03596010608079 ()
71067360

  • Device sterilization/disinfection container, 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
C-arm drape 42"x74" sterile, 20 per case
AADCO MEDICAL, INC.
DB-4274
In Commercial Distribution

  • 00840348526097 ()
  • 00840348525885 ()
DB-4274

  • Sterilization packaging, single-use
Stratus 42" Mattress - 2 Hose 1 per case
COMPASS HEALTH BRANDS CORP.
27300055
In Commercial Distribution

  • 00092237618028 ()


  • Alternating-pressure bed mattress overlay, reusable
Stratus 35" Mattress - 2 Hose 1 per case
COMPASS HEALTH BRANDS CORP.
27300054
In Commercial Distribution

  • 00092237618011 ()


  • Alternating-pressure bed mattress overlay, reusable
Stratus 42" On Demand Mattress 1 per case
COMPASS HEALTH BRANDS CORP.
27300049
In Commercial Distribution

  • 00092237617977 ()


  • Alternating-pressure bed mattress overlay, reusable
Stratus 35" On Demand Mattress 1 per case
COMPASS HEALTH BRANDS CORP.
27300048
In Commercial Distribution

  • 00092237617960 ()


  • Alternating-pressure bed mattress overlay, reusable
FFN 2 Base Set Tip-Loc™ Case Lid
Acumed LLC
80-3947
In Commercial Distribution

  • 10806378115349 ()


  • Instrument tray, reusable
FFN 2 Base Set Tip-Loc™ Case Base
Acumed LLC
80-3946
In Commercial Distribution

  • 10806378115332 ()


  • Instrument tray, reusable
Sterile Mobile XR Tube Drape, 20 per Case
TIDI PRODUCTS, LLC
30801
Not in Commercial Distribution

  • 01618125155278 ()


  • Medical equipment/instrument drape, single-use
Large Standalone Cage Implant & Trial Case (39 & 42mm)
PRECISION SPINE, INC.
69-SC-0400
In Commercial Distribution

  • 00840019968225 ()
69-SC-0400

  • Polymeric spinal interbody fusion cage
Standalone Cage Implant & Trial Case (30, 33, & 36mm)
PRECISION SPINE, INC.
69-SC-0100
In Commercial Distribution

  • 00840019968058 ()
69-SC-0100

  • Polymeric spinal interbody fusion cage
EXPEDIUM SPINE SYSTEM RING NUT CASE LID 4.5
DEPUY SPINE, LLC
279778000
In Commercial Distribution

  • 10705034301907 ()
279778000

  • Instrument tray, reusable
EXPEDIUM SPINE SYSTEM DEROTATION AND CONNECTION CASE & LID
DEPUY SPINE, LLC
279789007
In Commercial Distribution

  • 10705034203454 ()
279789007

  • Instrument tray, reusable
EXPEDIUM SPINE SYSTEM THREE LEVEL CASE AND LID
Medos International Sàrl
279784300
In Commercial Distribution

  • 10705034202648 ()
279784300

  • Instrument tray, reusable
EXPEDIUM SPINE SYSTEM TWO LEVEL CASE AND LID
Medos International Sàrl
279784200
In Commercial Distribution

  • 10705034202495 ()
279784200

  • Instrument tray, reusable
EXPEDIUM SPINE SYSTEM DUAL INNER CASE LICENSE PLATE
DEPUY SPINE, LLC
279782205
In Commercial Distribution

  • 10705034201368 ()
279782205

  • Instrument tray, reusable
MONARCH SPINE SYSTEM LOW BACK CORE INSTRUMENT CASE
DEPUY SPINE, LLC
277095000
Not in Commercial Distribution

  • 10705034197470 ()
277095000

  • Instrument tray, reusable
MOSS MIAMI SPINE SYSTEM LOW BACK IMPLANT CASE
DEPUY SPINE, LLC
274500100
In Commercial Distribution

  • 10705034192055 ()
274500100

  • Instrument tray, reusable
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