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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TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC32N
In Commercial Distribution

  • 50850025153473 ()
  • 10850025153475 ()
  • 00850025153478 ()
EMEC32N

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC29M
In Commercial Distribution

  • 10850025153468 ()
  • 00850025153461 ()
  • 50850025153466 ()
EMEC29M

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC25S
In Commercial Distribution

  • 50850025153459 ()
  • 10850025153451 ()
  • 00850025153454 ()
EMEC25S

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
SMEC41X
In Commercial Distribution

  • 50850025153442 ()
  • 10850025153444 ()
  • 00850025153447 ()
SMEC41X

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
SMEC36L
In Commercial Distribution

  • 50850025153435 ()
  • 10850025153437 ()
  • 00850025153430 ()
SMEC36L

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
SMEC32N
In Commercial Distribution

  • 50850025153428 ()
  • 10850025153420 ()
  • 00850025153423 ()
SMEC32N

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
SMEC29M
In Commercial Distribution

  • 50850025153411 ()
  • 10850025153413 ()
  • 00850025153416 ()
SMEC29M

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
SMEC25S
In Commercial Distribution

  • 50850025153404 ()
  • 10850025153406 ()
  • 00850025153409 ()
SMEC25S

  • Urinary incontinence penis sheath/port, single-use
PROG-003 External Power Accessories Kit (US)
Avertix Medical Inc.
0204-2100-093#P10
In Commercial Distribution

  • 00850012625100 ()
0204-2100-093#P10

  • Implantable cardiac device management application software
External Cardiac Compressor - Life-Stat Model 1008MII
MICHIGAN INSTRUMENTS, LLC
1008MII
In Commercial Distribution

  • 00860682000121 ()
16000

  • Cardiac resuscitator, pneumatic
External Cardiac Compressor - Thumper Model 1007CCV
MICHIGAN INSTRUMENTS, LLC
1007CCV
Not in Commercial Distribution

  • 00860682000114 ()
15370

  • Cardiac resuscitator, pneumatic
CABLE, EXTERNAL BATTERY EXTENSION, 1000 MM
MOBIUS BIONICS LLC
LU-60072-1000
In Commercial Distribution

  • 00859503006497 ()


  • Myoelectric hand prosthesis
CABLE, EXTERNAL BATTERY EXTENSION, 500 MM
MOBIUS BIONICS LLC
LU-60072-0500
In Commercial Distribution

  • 00859503006480 ()


  • Myoelectric hand prosthesis
External cooling system for Cool Coils
Tonica Elektronik A/S
Coil Cooler
In Commercial Distribution

  • 05713484030047 ()
9016B0151

  • Magnetic neural stimulation system
Silicone Male External Catheter. Self-Adhering. Non-Sterile.
Flex Source International, Inc.
Size 32MM - # 7732-30
In Commercial Distribution

  • 00860006105099 ()
  • 00860006105075 ()


  • Urinary incontinence penis sheath/port, single-use
Silicone Male External Catheter. Self-Adhering. Non-Sterile.
Flex Source International, Inc.
Size 29MM - # 7729-30
In Commercial Distribution

  • 00860006105051 ()
  • 00860006105037 ()


  • Urinary incontinence penis sheath/port, single-use
Standard Ratcheting T-Handle, External AO Connect
K2M, INC.
2601-90025
In Commercial Distribution

  • 10888857034860 ()
2601-90025

  • Surgical instrument handle, non-torque-limiting
Bi-furcated Contra Irrigation Tubing, Internal/External
OSTEOMED LLC
450-0420-04
In Commercial Distribution

  • 00845694012621 ()
450-0420-04

  • General internal orthopaedic fixation system implantation kit
External rotation guide , 3° x 11mm
UNITED ORTHOPEDIC CORP.
9303-2411-RD
In Commercial Distribution

  • 04719872174615 ()

  • 3° x 11mm
9303-2411-RD

  • Orthopaedic fixation implant alignment tool
External rotation guide, 3° X 9mm
UNITED ORTHOPEDIC CORP.
9303-2409-RE
In Commercial Distribution

  • 04719872174608 ()

  • 3° X 9mm
9303-2409-RE

  • Orthopaedic fixation implant alignment tool
External rotation guide , 3° x 9mm
UNITED ORTHOPEDIC CORP.
9303-2409-RD
In Commercial Distribution

  • 04719872174592 ()

  • 3° x 9mm
9303-2409-RD

  • Orthopaedic fixation implant alignment tool
Implant Rescue External Reg Screw Guide
SALVIN DENTAL SPECIALTIES, LLC
IMPLANT-RESCUE-EXT-R
In Commercial Distribution

  • 00841336109643 ()
IMPLANT-RESCUE-EXT-R

  • Dental torque wrench
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213020610 ()


  • Radiation therapy software
Male External Catheter,Foam Strap, Standard
Cardinal Health, Inc.
8884732398
In Commercial Distribution

  • 20884521025667 ()
  • 10884521025660 ()

  • Outer Diameter: 1.375 Inch
8884732398

  • Ureteral catheter
Adjustable Drill Guide - External Twist Mechanism
ALPHATEC SPINE, INC.
CI-11020
In Commercial Distribution

  • 00840180511480 ()


  • Surgical drill guide, reusable
KL RP DRILL GUIDE EXTERNAL CONNECTION
SOADCO, S.L.
KR 006
In Commercial Distribution

  • 08435451612298 ()
KR 006

  • Steel dental bur, reusable
30k External Water Universal Scaler Insert
PARKELL, INC.
DUE30
Not in Commercial Distribution

  • M595DUE300 ()
DUE30

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
25k External Water Universal Scaler Insert
PARKELL, INC.
DUE25
Not in Commercial Distribution

  • M595DUE250 ()
DUE25

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
30k External Water Perio Scaler Insert
PARKELL, INC.
DPE30
Not in Commercial Distribution

  • M595DPE300 ()
DPE30

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
25k External Water Perio Scaler Insert
PARKELL, INC.
DPE25
Not in Commercial Distribution

  • M595DPE250 ()
DPE25

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
1.8ML EXTERNAL 2D 1D/WP BULK
Nalge Nunc International Corporation
374502NOV
In Commercial Distribution

  • 30850016058530 ()
  • 10850016058536 ()
  • 80850016058535 ()


  • General specimen container IVD, no additive/medium
EXTERNAL DIAPHYSIS AXIS QUANTUM REUSABLE GUIDE
IN2BONES
M05 01341
In Commercial Distribution

  • 03701337607364 ()
M05 01341

  • Orthopaedic bur, reusable
Kubala External Drainage Catheter, 35 cm
SOPHYSA
FVPC4
In Commercial Distribution

  • 03760124134315 ()


  • Intracerebral infusion/drainage catheter, short-term
CareConnect™ External Female Catheter Regulator
BOEHRINGER LABORATORIES, LLC
7620
Not in Commercial Distribution

  • 70816286020897 ()
  • 10816286020895 ()
7620

  • Vacuum suction regulator/regulation set, general-purpose
JET-X MINI - UNILATERAL EXTERNAL FIXATOR SYSTEM
Smith & Nephew, Inc.
71067361
In Commercial Distribution

  • 03596010607799 ()
71067361

  • Instrument tray, reusable
Sterling P1500 printer, external w/ condenser
SKYTRON LLC
P1500-WC
In Commercial Distribution

  • 10841736110529 ()
P1500-WC

  • Surgical instrument washer/disinfector (chemical/thermal)
EXACTAMIX Cap - Large Bore, External Thread
BAXTER HEALTHCARE CORPORATION
H938711006
In Commercial Distribution

  • 50085412480058 ()
  • 00085412480053 ()
H938711006

  • Medicine bottle cap
PROFIX FEMORAL EXTERNAL ROTATION GUIDE NEUTRAL
Smith & Nephew, Inc.
71512456
Not in Commercial Distribution

  • 03596010223937 ()
71512456

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Oncentra External Beam Oncentra Brachy v4.6.1
Nucletron B.V.
170607-00
In Commercial Distribution

  • 08717213052758 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-08
In Commercial Distribution

  • 08717213052321 ()


  • Radiation therapy software
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