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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InCore Subtalar Instrument Case Lid
Medartis Inc.
ICSUBLID
In Commercial Distribution

  • 00817701028772 ()


  • Device sterilization/disinfection container, reusable
InCore TMT Instrument Case Lid
Medartis Inc.
IC-TMT-0123
In Commercial Distribution

  • 00817701026945 ()


  • Device sterilization/disinfection container, reusable
InCore MPJ Instrument Case Lid
Medartis Inc.
IC-MPJ-0123
In Commercial Distribution

  • 00817701026181 ()


  • Device sterilization/disinfection container, reusable
Hip Case 2, Acetabular Instruments
TOTAL JOINT ORTHOPEDICS, INC.
1406.00.000
In Commercial Distribution

  • 00819251021937 ()


  • Instrument tray, reusable
Hip Case 1, Femur Instruments
TOTAL JOINT ORTHOPEDICS, INC.
1405.00.000
In Commercial Distribution

  • 00819251021920 ()


  • Instrument tray, reusable
BiPolar Instrument Set Sterilization Case
TOTAL JOINT ORTHOPEDICS, INC.
1404.00.000
In Commercial Distribution

  • 00819251021913 ()


  • Instrument tray, reusable
Clearline Lumbar Complete Sterilization Case
Nsi US
NSI-3010G
In Commercial Distribution

  • G280NSI3010G0 ()
NSI-3010G

  • Instrument tray, reusable
A-SECURE FOAM, LARGE, BULK CASE
Bionix Radiation Therapy, LLC
BKRT-5038
Not in Commercial Distribution

  • 10817740020055 ()
  • 00817740020058 ()
BKRT-5038

  • Radiological whole-body positioner
B-SECURE FOAM, SMALL, BULK CASE
Bionix Radiation Therapy, LLC
BKRT-5036
Not in Commercial Distribution

  • 10817740020048 ()
  • 00817740020041 ()
BKRT-5036

  • Radiological whole-body positioner
B-SECURE FOAM, MEDIUM, BULK CASE
Bionix Radiation Therapy, LLC
BKRT-5037
Not in Commercial Distribution

  • 10817740020024 ()
  • 00817740020027 ()
BKRT-5037

  • Radiological whole-body positioner
PROMO Case Base, Full Din
Paragon 28, Inc.
P50-900-3102
In Commercial Distribution

  • 00889795056252 ()
P50-900-3102

  • Device sterilization/disinfection container, reusable
Monster Beam, Instrument Case Base
Paragon 28, Inc.
P26-900-INSB
In Commercial Distribution

  • 00889795055002 ()
P26-900-INSB

  • Device sterilization/disinfection container, reusable
Monster Beam, Implant Case Base
Paragon 28, Inc.
P26-900-IMPB
In Commercial Distribution

  • 00889795054869 ()
P26-900-IMPB

  • Device sterilization/disinfection container, reusable
Beaming Instrument Case, K-Wire Tray
Paragon 28, Inc.
P20-900-INSK
In Commercial Distribution

  • 00889795054746 ()
P20-900-INSK

  • Device sterilization/disinfection container, reusable
VERTEBRAL SPACER-AR LATERAL MODULE CASE
SYNTHES (U.S.A.) LP
305.011
Not in Commercial Distribution

  • H9813050110 ()
  • 10705034768342 ()
305011

  • Instrument tray, reusable
MODULE CASE FOR CSLP SCREWS
Synthes GmbH
304.983
In Commercial Distribution

  • H9813049830 ()
  • 10705034768212 ()
304983

  • Instrument tray, reusable
SMALL STATURE CSLP IMPLANT CASE
Synthes GmbH
304.898
In Commercial Distribution

  • H9813048980 ()
  • 10705034767857 ()
304898

  • Instrument tray, reusable
CERVICAL RETRACTOR/DISTRACTOR GRAPHIC CASE
Synthes GmbH
304.870
In Commercial Distribution

  • H9813048700 ()
  • 10705034767833 ()
304870

  • Instrument tray, reusable
CURETTE INSTRUMENT SET STERILIZATION CASE
Synthes GmbH
300.033
In Commercial Distribution

  • H9813000330 ()
  • 10705034767666 ()
300033

  • Instrument tray, reusable
Spinal Jaxx Bone Prep Case
NEUROPRO SPINAL JAXX INC.
100001-385
In Commercial Distribution

  • 00818956020757 ()
100001-385

  • Surgical instrument/implant rack
PLIF SG INSTRUMENTS CASE 2
DEPUY SPINE, LLC
273141000
Not in Commercial Distribution

  • 10705034187082 ()
273141000

  • Instrument tray, reusable
PLIF SG INSTRUMENTS MAIN CASE
DEPUY SPINE, LLC
273140000
Not in Commercial Distribution

  • 10705034187075 ()
273140000

  • Instrument tray, reusable
CUSTOM DIGITAL THERMTR W/CASE
APOTHECARY PRODUCTS, LLC
84815
Not in Commercial Distribution

  • 10025715848157 ()
  • 00025715848150 ()
  • 40025715848158 ()


  • Intermittent electronic patient thermometer
Implant Drill Stop Kit Case
OCO BIOMEDICAL INC
Implant Drill Stop Kit Case
In Commercial Distribution

  • D78562070 ()
6207

  • Surgical instrument/implant rack
ARCH FIXATION SYSTEM MODULE CASE
Synthes GmbH
304.924
In Commercial Distribution

  • H9813049240 ()
  • 10705034767949 ()
304924

  • Instrument tray, reusable
Mini-Monster Solid Screw, Case Caddy
Paragon 28, Inc.
P20-900-5003
In Commercial Distribution

  • 00889795018113 ()
P20-900-5003

  • Device sterilization/disinfection container, reusable
Mini-Monster Solid Screw, Case Tray
Paragon 28, Inc.
P20-900-5002
In Commercial Distribution

  • 00889795018106 ()
P20-900-5002

  • Device sterilization/disinfection container, reusable
Mini-Monster Solid Screw, Case Base
Paragon 28, Inc.
P20-900-5001
In Commercial Distribution

  • 00889795018090 ()
P20-900-5001

  • Device sterilization/disinfection container, reusable
COUGAR SYSTEM CASE AND TRAY
DEPUY SPINE, LLC
273250000
In Commercial Distribution

  • 10705034187945 ()
273250000

  • Instrument tray, reusable
ISOLA SPINE SYSTEM HOOK CASE
DEPUY SPINE, LLC
205094000
Not in Commercial Distribution

  • 10705034184838 ()
205094000

  • Instrument tray, reusable
T.L.I.F. SG INSTRUMENTS INSTRUMENT CASE
DEPUY SPINE, LLC
202719100
In Commercial Distribution

  • 10705034184609 ()
202719100

  • Instrument tray, reusable
Mouth to Mask, Hard Case
Allied Medical, LLC
L64186-M
In Commercial Distribution

  • 00026072011508 ()
  • 40026072011506 ()


  • Non-rebreathing oxygen face mask
VENT CIRCUIT,2M,5/CASE
Allied Medical, LLC
L599-280
In Commercial Distribution

  • 40026072022250 ()
  • 00026072022252 ()


  • Ventilator breathing circuit, single-use
VENT CIRCUIT CASE OF 10
Allied Medical, LLC
L599-130
In Commercial Distribution

  • 40026072022199 ()
  • 00026072022191 ()


  • Ventilator breathing circuit, single-use
WATER,TRAP,MEDLINE,25/CASE
Allied Medical, LLC
HCS2503
In Commercial Distribution

  • 00026072025383 ()


  • Breathing circuit condensate trap, single-use
Irix A Sterlization Case, Secondary
Xtant Medical Holdings, Inc.
X080-0006
In Commercial Distribution

  • M697X08000060 ()
  • M697X08000061 ()


  • Instrument tray, reusable
Irix A Sterlization Case, Primary
Xtant Medical Holdings, Inc.
X080-0005
In Commercial Distribution

  • M697X08000050 ()
  • M697X08000051 ()


  • Device sterilization/disinfection container, reusable
H-Graft System Instrument Sterilization Case
Xtant Medical Holdings, Inc.
X078-0003
In Commercial Distribution

  • M697X07800031 ()


  • Cadaveric-donor bone allograft
ACC. SLIM-RIC BT CHARGING CASE
Ws Audiology Usa, Inc.
SLIM-RIC BT CHARGING CASE
In Commercial Distribution

  • 04063006001194 ()
10962493

  • Noninvasive device battery charger
Sterilization Case I, Atrix-C, Instruments
Xtant Medical Holdings, Inc.
X094-0003
In Commercial Distribution

  • M697X09400030 ()
  • M697X09400031 ()


  • Cadaveric-donor bone allograft
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