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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UNIVERS CA HUMERAL HEAD, 46/20
ARTHREX, INC.
AR-9146-20CA
In Commercial Distribution

  • 00888867136083 ()
  • M150AR914620CA1 ()
AR-9146-20CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 46/18
ARTHREX, INC.
AR-9146-18CA
In Commercial Distribution

  • 00888867136052 ()
  • M150AR914618CA1 ()
AR-9146-18CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 44/19
ARTHREX, INC.
AR-9144-19CA
In Commercial Distribution

  • 00888867135611 ()
  • M150AR914419CA1 ()
AR-9144-19CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 44/17
ARTHREX, INC.
AR-9144-17CA
In Commercial Distribution

  • 00888867135581 ()
  • M150AR914417CA1 ()
AR-9144-17CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 42/17
ARTHREX, INC.
AR-9142-17CA
In Commercial Distribution

  • 00888867135505 ()
  • M150AR914217CA1 ()
AR-9142-17CA

  • Uncoated shoulder humeral stem prosthesis
CUSTOM PACK BB11S99R10 CHICO CA 1
MEDTRONIC, INC.
BB11S99R10
In Commercial Distribution

  • 00763000723989 ()


  • Cardiopulmonary bypass system blood tubing set
Gs/Gw Drive Lock CA Long
INTRA-LOCK INTERNATIONAL, INC.
SDLCAL
In Commercial Distribution

  • D742SDLCAL0 ()
SDLCAL

  • Dental implant system
One Piece™ Implant CA Driver
INTRA-LOCK INTERNATIONAL, INC.
OPCAD
In Commercial Distribution

  • D742OPCAD0 ()
OPCAD

  • Dental implant system
CUSTOM PACK HY10J00R12 ECC SMALL CA
MEDTRONIC, INC.
HY10J00R12
In Commercial Distribution

  • 00763000467449 ()


  • Cardiopulmonary bypass system blood tubing set
SYRINGE 10CC GREEN CA LAN 50C
DEROYAL INDUSTRIES, INC.
77-400598
In Commercial Distribution

  • 50749756627240 ()
  • 00749756627245 ()


  • Angiographic syringe
GENERATOR RDNG3A G3SV5.1 US JP CA
MEDTRONIC, INC.
RDNG3A
In Commercial Distribution

  • 00763000387020 ()


  • Percutaneous radio-frequency ablation system generator
CUSTOM PACK BB11S99R12 CHICO CA 1
MEDTRONIC, INC.
BB11S99R12
In Commercial Distribution

  • 00763000848446 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R11 CHICO CA 1
MEDTRONIC, INC.
BB11S99R11
In Commercial Distribution

  • 00763000845018 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R2 CHICO CA 1
MEDTRONIC, INC.
BB11S99R2
In Commercial Distribution

  • 00763000630225 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R15 CHICO CA 1
MEDTRONIC, INC.
BB11S99R15
In Commercial Distribution

  • 00763000927394 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB5305R1 SUPP W/CA
MEDTRONIC, INC.
CB5305R1
Not in Commercial Distribution

  • 00885074241166 ()


  • Cardiopulmonary bypass system blood tubing set
KIT PORTUGUESE HD 1200 AUTOCLAVABLE CA
Smith & Nephew, Inc.
72203408
Not in Commercial Distribution

  • 00885554027464 ()
72203408

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ProStim Electrodes, 2" Square, ca/40
ALIMED, INC.
31700
In Commercial Distribution

  • 00733657258332 ()

  • Square
  • Length: 2 Inch
31700

  • Transcutaneous electrical stimulation electrode, single-use
Transmucosal Abutment 4mm & 5mm Diameter
OCO BIOMEDICAL INC
TSI/ERI Transmucosal Abutment 4mm & 5mm
In Commercial Distribution

  • D7854CATA0 ()
4.0 CA

  • Dental implant system
TSI/ERI Transmucosal Abutment 3.25mm 3.25mm Diameter
OCO BIOMEDICAL INC
TSI/ERI Transmucosal Abutment 3.25mm
In Commercial Distribution

  • D785325CATA0 ()
3.25 CA

  • Dental implant suprastructure, permanent, preformed
INFINITY OS CASS,PURPLE,E7,C4,C2 ACC,AW2
HU-FRIEDY MFG. CO., LLC
IMNOS4E/CA
In Commercial Distribution

  • 10889950070731 ()
IMNOS4E/CA

  • Device sterilization/disinfection container, reusable
ASSISTO R310MM W DETACHABLE U-STAND
GEOMED Medizin-Technik GmbH & Co. KG
CA 305-22-01
In Commercial Distribution

  • 14049679076803 ()
CA 305-22-01

  • Surgical instrument assist arm system, manually-adjusted
ASSISTO R310MM U-STAND 400X400X170MM WITH UNIVERSAL RETRACTOR HOLDER
GEOMED Medizin-Technik GmbH & Co. KG
CA 301-20-01
In Commercial Distribution

  • 14049679076735 ()
CA 301-20-01

  • Surgical instrument assist arm system, manually-adjusted
ASSISTO R310MM L-STAND 134X170MM WITH UNIVERSAL RETRACTOR HOLDER
GEOMED Medizin-Technik GmbH & Co. KG
CA 235-30-01
In Commercial Distribution

  • 14049679076681 ()
CA 235-30-01

  • Surgical instrument assist arm system, manually-adjusted
BETHUNE RIB SHEAR HANDLES WITH RUBBER COVER LENGTH 340 MM
Gimmi GmbH
CA.1153.34
In Commercial Distribution

  • 04049047176220 ()
CA.1153.34

  • Bone cutting forceps, reusable
GIERTZ-STILLE RIB SHEAR LENGTH 270 MM
Gimmi GmbH
CA.1140.27
In Commercial Distribution

  • 04049047031666 ()
CA.1140.27

  • Bone cutting forceps, reusable
COLLIN RIB SHEAR LENGTH 195 MM
Gimmi GmbH
CA.1104.22
In Commercial Distribution

  • 04049047694526 ()
CA.1104.22

  • Bone cutting forceps, reusable
LEBSCHE STERNUM CHISEL LENGTH 245 MM
Gimmi GmbH
CA.1154.24
In Commercial Distribution

  • 04049047031697 ()
CA.1154.24

  • Orthopaedic chisel
BRUNNER RIB SHEAR LENGTH 320 MM
Gimmi GmbH
CA.1152.28
In Commercial Distribution

  • 04049047031680 ()
CA.1152.28

  • Bone cutting forceps, reusable
RIB SHEAR LENGTH 220 MM
Gimmi GmbH
CA.1104.22
In Commercial Distribution

  • 04049047031628 ()
CA.1104.22

  • Bone cutting forceps, reusable
PLIF Tray
PRECISION SPINE, INC.
21-1001 CA
In Commercial Distribution

  • 00840019923910 ()
21-1001 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable
TPLIF Tray/TLIF Tray
PRECISION SPINE, INC.
21-1002 CA
In Commercial Distribution

  • 00840019923897 ()
21-1002 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable
TPLIF/TLIF Instrument Tray
PRECISION SPINE, INC.
21-1008 CA
In Commercial Distribution

  • 00840019923873 ()
21-1008 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable
TLIF/ PLIF/ TPLIF system
PRECISION SPINE, INC.
21-1007 CA
In Commercial Distribution

  • 00840019923866 ()
21-1007 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable
IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002680 ()
800-7702

  • Multiple urine analyte IVD, control
IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002611 ()
800-7211

  • Multiple urine analyte IVD, control
EXTRA SHORT RETENTIVE CA DRIVER OUTLINK2-GLOBAL MOUNTER
SWEDEN & MARTINA SPA
E2-AVV3-MOUC-CA
In Commercial Distribution

  • D7701107403 ()
E2-AVV3-MOUC-CA

  • Dental implant/prosthesis surgical procedure kit
Univers Revers CA Head & 155 Trials Case
ARTHREX, INC.
AR-9501H-CA155C
In Commercial Distribution

  • 00888867399372 ()
AR-9501H-CA155C

  • Device sterilization/disinfection container, reusable
Personal Use Kit OC-Auto, for Mather, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 213264
In Commercial Distribution

  • 00816917021706 ()


  • Faecal occult blood IVD, reagent
TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
TRI-ANIM HEALTH SERVICES, INC.
301-160EA
In Commercial Distribution

  • 00818834021432 ()
  • 00818834020893 ()
  • 00818834021975 ()
301-160EA

  • Oxygen administration tubing
VITROS Immunodiagnostic Products CA 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6177751
In Commercial Distribution

  • 10758750034901 ()
6177751

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6177747
In Commercial Distribution

  • 20758750034830 ()
  • 10758750034833 ()
6177747

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802241
In Commercial Distribution

  • 10758750002351 ()
  • 20758750002358 ()
6802241

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801758
In Commercial Distribution

  • 10758750001323 ()
  • 20758750001320 ()
6801758

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800034
In Commercial Distribution

  • 10758750000548 ()
  • 20758750000545 ()
6800034

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
E-Type K-Style CA 1:1 Latch Chuck
SIRONA Dental Systems GmbH
710430
In Commercial Distribution

  • E2767104300 ()


  • Dental power tool handpiece motorless component
EASY MOUNTER PREMIUM ONE CA, SLEEVE 550
SWEDEN & MARTINA SPA
GS-EASY-AS-550-CA
In Commercial Distribution

  • D7701515563 ()
GS-EASY-AS-550-CA

  • Surgical screwdriver, reusable
EASY MOUNTER PREMIUM ONE CA, SLEEVE 415
SWEDEN & MARTINA SPA
GS-EASY-AS-415-CA
In Commercial Distribution

  • D7701515553 ()
GS-EASY-AS-415-CA

  • Surgical screwdriver, reusable
PrimePlus Bariatric Bed, 750 lb. Wgt Ca
Drive Devilbiss Healthcare
P1752
Not in Commercial Distribution

  • 00822383550626 ()


  • Bariatric bed
EasyLyte Na/K/Cl/Ca/Li Analyzer
MEDICA CORPORATION
2030
In Commercial Distribution

  • 00386100002930 ()
2030

  • Ion-selective analyser IVD
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