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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Mini CFS, Instr Case Base, Insert, & Lid
ARTHREX, INC.
AR-18700C
In Commercial Distribution

  • 00888867317840 ()
AR-18700C

  • Device sterilization/disinfection container, reusable
Implant Case APTUS Dist. Ulna Plates 2.5
Medartis AG
A-6602.117
In Commercial Distribution

  • 07630894801747 ()
A-6602.117

  • Device sterilization/disinfection container, reusable
Case CCS 2.2, 3.0, Add-On Foot Mini
Medartis AG
A-6603.035
In Commercial Distribution

  • 07630894811098 ()
A-6603.035

  • Device sterilization/disinfection container, reusable
Case CCS 2.2, 3.0, Add-On Hand Mini
Medartis AG
A-6603.032
In Commercial Distribution

  • 07630894811067 ()
A-6603.032

  • Device sterilization/disinfection container, reusable
Implant Case APTUS Foot Plates 2.8/3.5
Medartis AG
A-6601.030
In Commercial Distribution

A-6601.030

  • Device sterilization/disinfection container, reusable
Implant Case APTUS Foot Screws 2.0/2.3
Medartis AG
A-6601.026
In Commercial Distribution

A-6601.026

  • Device sterilization/disinfection container, reusable
Implant Case APTUS Foot Plates 2.0/2.3
Medartis AG
A-6601.025
In Commercial Distribution

A-6601.025

  • Device sterilization/disinfection container, reusable
SIGMA FEMORAL ADAPTER INSTRUMENT CASE TRAY 1
DEPUY ORTHOPAEDICS, INC.
96-1691
In Commercial Distribution

  • 10603295239871 ()
961691

  • Instrument tray, reusable
SIGMA 150 FIXED REFERENCE FEMORAL PREP CASE
DEPUY (IRELAND)
9505-02-860
In Commercial Distribution

  • 10603295229803 ()
950502860

  • Instrument tray, reusable
SIGMA HP BIOSKILLS CASE 2 SIZE 2.5
DEPUY ORTHOPAEDICS, INC.
9505-02-850
In Commercial Distribution

  • 10603295229742 ()
950502850

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE REVISION FEMORAL PREP CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-847
In Commercial Distribution

  • 10603295229728 ()
950502847

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE FB MACRO TRIAL CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-834
In Commercial Distribution

  • 10603295229605 ()
950502834

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE MACRO RP INSERT CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-832
In Commercial Distribution

  • 10603295229582 ()
950502832

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE QUICK KIT MBT CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-824
In Commercial Distribution

  • 10603295229513 ()
950502824

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE QUICK KIT BASE CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-823
In Commercial Distribution

  • 10603295229506 ()
950502823

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE FB TIBIA PREP CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-812
In Commercial Distribution

  • 10603295229407 ()
950502812

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE BALANCED FEMUR PREP CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-811
In Commercial Distribution

  • 10603295229391 ()
950502811

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE CLASSIC FEMUR PREP CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-810
In Commercial Distribution

  • 10603295229384 ()
950502810

  • Instrument tray, reusable
SIGMA HIGH PERFORMANCE RP INSERT TRIALS CASE
DEPUY ORTHOPAEDICS, INC.
9505-02-807
In Commercial Distribution

  • 10603295229353 ()
950502807

  • Instrument tray, reusable
Femoral Nail System, Case 2 of 2
ARTHREX, INC.
AR-9097C-02
In Commercial Distribution

  • 00888867446076 ()
AR-9097C-02

  • Device sterilization/disinfection container, reusable
Femoral Nail System, Case 1 of 2
ARTHREX, INC.
AR-9097C-01
In Commercial Distribution

  • 00888867446069 ()
AR-9097C-01

  • Device sterilization/disinfection container, reusable
DURA-STICK PREM 3"X5" OV 20/CASE
DJO, LLC
42173
In Commercial Distribution

  • 00888912023573 ()


  • Transcutaneous electrical stimulation electrode, single-use
DURA-STICK P 1.5"X2.5" OV 40/CASE
DJO, LLC
42172
In Commercial Distribution

  • 00888912023566 ()


  • Transcutaneous electrical stimulation electrode, single-use
DEPUY REACH KNEE CASE 4 CRUCIATE - RETAINING
DEPUY (IRELAND)
9505-05-553
In Commercial Distribution

  • 10603295445272 ()
950505553

  • Instrument tray, reusable
INHANCE SHOULDER SYSTEM TRIAL AUGMENT CASE COMPLETE
DEPUY (IRELAND)
6005-30-306
In Commercial Distribution

  • 10603295550112 ()
600530306

  • Instrument tray, reusable
ATTUNE KNEE SYSTEM REVISION FEMORAL BROACHING CASE
DEPUY (IRELAND)
2549-00-160
In Commercial Distribution

  • 10603295476528 ()
254900160

  • Instrument tray, reusable
ATTUNE KNEE SYSTEM REVISION STEM TRIALS CASE
DEPUY (IRELAND)
2549-00-080
In Commercial Distribution

  • 10603295476504 ()
254900080

  • Instrument tray, reusable
INHANCE SHOULDER SYSTEM GENERAL INSTRUMENT CASE COMPLETE
DEPUY (IRELAND)
6005-30-301
In Commercial Distribution

  • 10603295546139 ()
600530301

  • Instrument tray, reusable
ATTUNE KNEE SYSTEM REVISION PINNING & SPACING CASE
DEPUY (IRELAND)
2549-00-100
In Commercial Distribution

  • 10603295476498 ()
254900100

  • Instrument tray, reusable
ATTUNE KNEE SYSTEM REVISION CANAL REAMERS CASE
DEPUY (IRELAND)
2549-00-090
In Commercial Distribution

  • 10603295476474 ()
254900090

  • Instrument tray, reusable
CASE, EMPOWR 3D KNEETM FEM PREP-TRIAL, SMALL
Encore Medical, L.P.
800-99-101
In Commercial Distribution

  • 00888912168823 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ELECTRODES DURA-STICK PIN 2X3.5IN RECT 40/CASE
DJO, LLC
42179
In Commercial Distribution

  • 00888912340816 ()


  • Transcutaneous electrical stimulation electrode, single-use
DURA-STICK BG 1.5"X3.5" REC 40/CASE
DJO, LLC
42177
In Commercial Distribution

  • 00888912340809 ()


  • Transcutaneous electrical stimulation electrode, single-use
DURA-STICK P 2"X3.5" REC 40/CASE
DJO, LLC
42175
In Commercial Distribution

  • 00888912340786 ()


  • Transcutaneous electrical stimulation electrode, single-use
CASE, FND PS 3, 5, 7 TRL
Encore Medical, L.P.
800-99-053
In Commercial Distribution

  • 00888912142397 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
CASE, EMPOWR PS KNEETM TIBIAL TRIALS, CORE
Encore Medical, L.P.
800-99-118
In Commercial Distribution

  • 00888912545365 ()


  • Instrument tray, reusable
CASE, EMPOWR PS KNEETM FEMORAL TRIALS, CORE
Encore Medical, L.P.
800-99-117
In Commercial Distribution

  • 00888912545358 ()


  • Instrument tray, reusable
Royal Oak IBFD Instrument Set Case 2
Royal Oak Medical Devices LLC
4502081
In Commercial Distribution

  • 00812352021295 ()


  • External spinal fixation system
Royal Oak IBFD Instrument Set Case 1
Royal Oak Medical Devices LLC
4501081
In Commercial Distribution

  • 00812352021288 ()


  • External spinal fixation system
NovoHip DAA Femoral Prep Case - Level 3
Novosource, LLC
1611-100-001
In Commercial Distribution

  • 00811382038853 ()
1611-100-001

  • Joint prosthesis implantation kit, reusable
CASE AMALGAM GOLD KIT 2ND YR 1P
Peter Brasseler Holdings, LLC
5012085U0
In Commercial Distribution

  • 00887919558897 ()


  • Diamond dental bur, single-use
Fall Guardian Motion Sensor and Pager case
Smart Caregiver Corporation
FGPM/CS
In Commercial Distribution

  • 00812293015452 ()


  • Nurse call system
FallGuard Economy Monitor with chair pad case
Smart Caregiver Corporation
FG2C90-SYS/CS
In Commercial Distribution

  • 00812293015315 ()


  • Bed/chair occupant movement pressure/vibration sensor
Phonak Charger Case Combi incl. UK EPS
Sonova AG
075-0040-13
In Commercial Distribution

  • 07613389478969 ()
075-0040-13

  • Noninvasive device battery charger
Phonak Charger Case Combi incl. JP EPS
Sonova AG
075-0040-16
In Commercial Distribution

  • 07613389478952 ()
075-0040-16

  • Noninvasive device battery charger
Phonak Charger Case Combi incl. IN EPS
Sonova AG
075-0040-18
In Commercial Distribution

  • 07613389478945 ()
075-0040-18

  • Noninvasive device battery charger
Phonak Charger Case Combi incl. KO EPS
Sonova AG
075-0040-17
In Commercial Distribution

  • 07613389446579 ()
075-0040-17

  • Noninvasive device battery charger
Easy Line Charger Case (no power supply)
Unitron Hearing Division
075-5840
In Commercial Distribution

  • 07613389220650 ()
075-5840

  • Noninvasive device battery charger
Phonak Charger Case Combi incl. EU EPS
Sonova AG
075-0040-12
In Commercial Distribution

  • 07613389177824 ()


  • Noninvasive device battery charger
Implant Case Assembly, SPIRA Open Matrix ALIF
CAMBER SPINE TECHNOLOGIES, LLC
SPA-500-001
In Commercial Distribution

  • B030SPA5000010 ()


  • Instrument tray, reusable
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