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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7106-7376 JET-X 6 HOLE PIN CLAMPMR CO
MEDLINE INDUSTRIES, INC.
71067376RH
In Commercial Distribution

  • 10193489002546 ()
71067376RH

  • External orthopaedic fixation system reprocessed component
7106-7375 JET-X 4 HOLE PIN CLAMPMR CO
MEDLINE INDUSTRIES, INC.
71067375RH
In Commercial Distribution

  • 10193489002539 ()
71067375RH

  • External orthopaedic fixation system reprocessed component
7106-4009 JET-X BAR TO PIN CLAMPMR CO
MEDLINE INDUSTRIES, INC.
71064009RH
In Commercial Distribution

  • 10193489002348 ()
71064009RH

  • External orthopaedic fixation system reprocessed component
SAMPLING LINE, 10ft, Co/Ext, M/M
King Systems Corporation
7073
In Commercial Distribution

  • 00612649112183 ()
  • 00612649191065 ()
7073

  • Gas-sampling/monitoring respiratory tubing, single-use
SAMPLING LINE, 10ft, Co/Ext, M/F
King Systems Corporation
7031
In Commercial Distribution

  • 00612649112039 ()
  • 00612649190990 ()
7031

  • Gas-sampling/monitoring respiratory tubing, single-use
PK CUST CV A&B CABRINI CO
MEDLINE INDUSTRIES, INC.
DYNJ60583
In Commercial Distribution

  • 10193489523676 ()
DYNJ60583

  • General surgical procedure kit, non-medicated, single-use
1" Dia. Left Right Markers Co 57
RADQUAL, LLC
BM03-57 L&R
In Commercial Distribution

  • 00850020470136 ()


  • Radiographic image marker, manual
Square 12" x 12" Phantom Co 57
RADQUAL, LLC
BM55
In Commercial Distribution

  • 00850020470051 ()


  • Nuclear medicine phantom, flood source
Rect 10" x 16" Phantom Co 57
RADQUAL, LLC
BM07
In Commercial Distribution

  • 00850020470044 ()


  • Nuclear medicine phantom, flood source
Rect 14" x 18" Phantom Co 57
RADQUAL, LLC
BM04
In Commercial Distribution

  • 00850020470020 ()


  • Nuclear medicine phantom, flood source
8226 CO/CO2 REB 8200/2600/8201
HANS RUDOLPH, INC.
8200
Not in Commercial Distribution

  • 00874750008421 ()
112281

  • Pulmonary function valve
8227 CO/CO2 REB 8200/2700/8201
HANS RUDOLPH, INC.
8200
Not in Commercial Distribution

  • 00874750008414 ()
112280

  • Pulmonary function valve
PKG,CHG KIT,CO,PREM3,CFF3,US
Gn Hearing A/S
21973300
In Commercial Distribution

  • 05708296218868 ()


  • Noninvasive device battery charger
PKG,CHGR PREM3,C-1,CO,CFF2,US
Gn Hearing A/S
21849700
In Commercial Distribution

  • 05708296216956 ()


  • Noninvasive device battery charger
PKG,CHGR STD,C-2,CO,CFF2,US
Gn Hearing A/S
21849100
In Commercial Distribution

  • 05708296216925 ()


  • Noninvasive device battery charger
SPEC 8-INSTR WHITE/LAVNDR BASE, WHITE CO
HU-FRIEDY MFG. CO., LLC
IM508262
Not in Commercial Distribution

  • 10889950056018 ()
IM508262

  • Device sterilization/disinfection container, reusable
SPEC 5-INSTR LAVNDR/PINK BASE, LAVNDR CO
HU-FRIEDY MFG. CO., LLC
IM60560106
In Commercial Distribution

  • 10889950059170 ()
IM60560106

  • Device sterilization/disinfection container, reusable
Personal Use Kit OC-Auto, for Denver, CO
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2333555
In Commercial Distribution

  • 00816917021836 ()


  • Faecal occult blood IVD, reagent
LUM LAM CUSTOM PACK F/ CO CUSTOM
HENRY SCHEIN, INC.
5702914
In Commercial Distribution

  • 00304040168257 ()
  • 10304040168254 ()
5702914

  • General surgical procedure kit, non-medicated, single-use
*Custom* Kent CO DE IV Start Kit
BOUND TREE MEDICAL, LLC
8600-01437
In Commercial Distribution

  • 00812277036145 ()
8600-01437

  • Peripheral intravenous catheterization support kit
KIT DECOMPRESSION KIT FOR QUEEN ANNE'S CO
BOUND TREE MEDICAL, LLC
QASEEPNEK
In Commercial Distribution

  • 00812277033748 ()
QASEEPNEK

  • Pneumothorax catheter insertion set
KUP2 KOIS UNIV CO (M) FL 3P
Peter Brasseler Holdings, LLC
5030930U0
In Commercial Distribution

  • 00887919964988 ()


  • Dental abrasive point, reusable
ENNOVATE TRAY OPEN BELOW SCRW.HEAD CO/DI
Aesculap AG
SZ221R
In Commercial Distribution

  • 04046955198252 ()
SZ221R

  • Surgical instrument/implant rack
ENNOVATE MIS C-RING FOR CO/DI DEVICE
Aesculap AG
SZ395R
In Commercial Distribution

  • 04046964720338 ()
SZ395R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
KIT,ANE UNIV OF CO 30 CS
Cardinal Health 200, LLC
ANE458811D
In Commercial Distribution

  • 50885425102004 ()
  • 10885425102006 ()
ANE458811D

  • General surgical procedure kit, non-medicated, single-use
DBD-LAP,APPLIER,LIGACLIP,ROT,ETHI,MED,CO
MEDLINE INDUSTRIES, INC.
MDS708741EM
In Commercial Distribution

  • 10884389183397 ()
MDS708741EM

  • Flexible endoscopic tissue manipulation forceps, reusable
HS27 HFF W96/48 EVERY OTHER CO
DIAGNOSTIC HYBRIDS, INC.
87-9648C
In Commercial Distribution

  • 30014613334545 ()
87-9648C

  • Cell culture line IVD
CUSTOM PACK BB10R23R1 5PK GV DELNIDO CO
MEDTRONIC, INC.
BB10R23R1
In Commercial Distribution

  • 20763000446400 ()
  • 00763000446390 ()


  • Cardiopulmonary bypass system blood tubing set
PK CUST CV A&B CABRINI CO
MEDLINE INDUSTRIES, INC.
DYNJ60583D
In Commercial Distribution

  • 10195327680831 ()
DYNJ60583D

  • General surgical procedure kit, non-medicated, single-use
X LARGE RADIAL HEAD PROSTHESIS - CO CR
Smith & Nephew, Inc.
71927097
Not in Commercial Distribution

  • 00885556044629 ()
71927097

  • Elbow radius prosthesis
PK CUST CV A&B CABRINI CO
MEDLINE INDUSTRIES, INC.
DYNJ60583C
In Commercial Distribution

  • 10195327605582 ()
DYNJ60583C

  • General surgical procedure kit, non-medicated, single-use
PK CUST CV A&B CABRINI CO
MEDLINE INDUSTRIES, INC.
DYNJ60583B
In Commercial Distribution

  • 10195327547769 ()
DYNJ60583B

  • General surgical procedure kit, non-medicated, single-use
DBD-CANNULA,COMFORT SOFT,HF,NEONATAL,2"
MEDLINE INDUSTRIES, INC.
HCS4520HF
In Commercial Distribution

  • 40888277101495 ()
  • 10888277101494 ()
HCS4520HF

  • Oxygen administration tubing
SCISSORS 5 MM, HF MONOP. BNDL
Richard Wolf GmbH
840550103
Not in Commercial Distribution

  • 04055207057902 ()
84055.0103

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
SPOON HOLDER 5 MM, HF MONOP.
Richard Wolf GmbH
840442809
Not in Commercial Distribution

  • 04055207057841 ()
84044.2809

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
SPOON HOLDER 5 MM, HF MONOP.
Richard Wolf GmbH
840442804
Not in Commercial Distribution

  • 04055207057834 ()
84044.2804

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Phasitron Kit, HF Transport, Single Patient
PERCUSSIONAIRE CORPORATION
A50605-D
In Commercial Distribution

  • 10849436000331 ()
  • 00849436000334 ()
A50605-D

  • Ventilator breathing circuit, single-use
UltraScan Versa, H-F, Calf, Stirrup, 2AD
MEDICAL POSITIONING, INC.
987
In Commercial Distribution

  • 00848871001319 ()


  • Multi-purpose diagnostic imaging table
UltraScan Versa, H-F, Calf, Stirrup, 2D
MEDICAL POSITIONING, INC.
287
In Commercial Distribution

  • 00848871001296 ()


  • Multi-purpose diagnostic imaging table
Cauteries, Button Tip, 33cm, HF Port
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
11-1210
In Commercial Distribution

  • 00848657012584 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
HF Micro Tissue Pliers, Diamond Dust.
HU-FRIEDY MFG. CO., LLC
8-905DD
In Commercial Distribution

  • 10889950004200 ()
8-905DD

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
5mm 45cm J-Hook Electrode, HF Port
Surgical Direct, Inc.
SD1185945.100
In Commercial Distribution

  • B382SD11859451000 ()
SD1185945.100

  • Flexible endoscopic tissue manipulation forceps, single-use
5mm 45cm J-Hook Electrode, HF Port
Surgical Direct, Inc.
SD1185945
In Commercial Distribution

  • B382SD11859450 ()

  • Length: 45 Centimeter
  • Outer Diameter: 5 Millimeter
SD1185945

  • Endoscope sheath, reusable
CONIC OBTR,HF 3MM SCOPE SHTH
ARTHREX, INC.
AR-3375-0301
In Commercial Distribution

  • 00888867030206 ()
AR-3375-0301

  • Endoscope sheath, reusable
Porcelain Etchant (9.5% HF) Refill Pkg
BISCO INC.
E-5707P
Not in Commercial Distribution

  • D757E5707P1 ()
E-5707P

  • Dental etching solution
Porcelain Etchant (9.5% HF) 5gm Syr
BISCO INC.
E-5707
Not in Commercial Distribution

  • D757E57070 ()
E-5707

  • Dental etching solution
Porcelain Etchant (4% HF) 5gm syringe
BISCO INC.
E-5702E
Not in Commercial Distribution

  • D757E5702E0 ()
E-5702E

  • Dental etching solution
STD, AVA, 3L, 9F, HF, KIC
MEDLINE INDUSTRIES, INC.
ECVC8100A
In Commercial Distribution

  • 00653160368741 ()
  • 10653160368748 ()
ECVC8100A

  • General surgical procedure kit, medicated
9F AVA HF RESUSCIT CVC BNDL
MEDLINE INDUSTRIES, INC.
ECVC6640
In Commercial Distribution

  • 00653160363678 ()
  • 10653160363675 ()
ECVC6640

  • General surgical procedure kit, medicated
AVA HF 9F 3L, US,BAS
MEDLINE INDUSTRIES, INC.
STCVC44US
In Commercial Distribution

  • 00653160347968 ()
  • 10653160347965 ()
STCVC44US

  • Central venous catheterization kit, short-term
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