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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EXTERNAL OCULID TAN® - 1,0 g
FCI S A S FCI 20 22
S3.60102
In Commercial Distribution

  • 13700773727718 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,0 g
FCI S A S FCI 20 22
S3.60101
In Commercial Distribution

  • 13700773727701 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,0 g
FCI S A S FCI 20 22
S3.60100
In Commercial Distribution

  • 13700773727695 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 0,8 g
FCI S A S FCI 20 22
S3.60082
In Commercial Distribution

  • 13700773727664 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 0,8 g
FCI S A S FCI 20 22
S3.60081
In Commercial Distribution

  • 13700773727657 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 0,8 g
FCI S A S FCI 20 22
S3.60080
In Commercial Distribution

  • 13700773727640 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 0,6 g
FCI S A S FCI 20 22
S3.60062
In Commercial Distribution

  • 13700773727619 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 0,6 g
FCI S A S FCI 20 22
S3.60061
In Commercial Distribution

  • 13700773727602 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 0,6 g
FCI S A S FCI 20 22
S3.60060
In Commercial Distribution

  • 13700773727596 ()


  • Eyelid weight, external
DRG External Pulse Generator, 8 Channel
ST. JUDE MEDICAL, INC.
7599
In Commercial Distribution

  • 05415067027122 ()
7599

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
DBS External Pulse Generator, 16 Channel
ST. JUDE MEDICAL, INC.
6599
In Commercial Distribution

  • 05415067023667 ()
6599

  • Deep brain electrical stimulation system
External Battery Event Marker Cable Kit
ADVANCED BRAIN MONITORING, INC.
UN03-5206
In Commercial Distribution

  • 00850015266911 ()


  • Electrical-only medical device connection cable, reusable
External Pulse Generator, 2 Port Header
ADVANCED NEUROMODULATION SYSTEMS, INC.
3042
In Commercial Distribution

  • 05415067051882 ()
3042

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
Solo Pace Control External Pulse Generator
SOLO PACE INC.
SOLOEPG1L
In Commercial Distribution

  • 00850056280037 ()


  • External pacemaker, epicardial pacing
ActiveFlow External Breast Form Size 14
Trulife Limited
0063014
In Commercial Distribution

  • 00645517612874 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 13
Trulife Limited
0063013
In Commercial Distribution

  • 00645517612850 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 12
Trulife Limited
0063012
In Commercial Distribution

  • 00645517612836 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 10
Trulife Limited
0063010
In Commercial Distribution

  • 00645517612799 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 08
Trulife Limited
0063008
In Commercial Distribution

  • 00645517612751 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 06
Trulife Limited
0063006
In Commercial Distribution

  • 00645517612713 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 04
Trulife Limited
0063004
In Commercial Distribution

  • 00645517612676 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 02
Trulife Limited
0063002
In Commercial Distribution

  • 00645517723716 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 01
Trulife Limited
0063001
In Commercial Distribution

  • 00645517723693 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 11
Trulife Limited
0063011
In Commercial Distribution

  • 00645517612812 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 09
Trulife Limited
0063009
In Commercial Distribution

  • 00645517612775 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 07
Trulife Limited
0063007
In Commercial Distribution

  • 00645517612737 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 05
Trulife Limited
0063005
In Commercial Distribution

  • 00645517612690 ()


  • External breast prosthesis
ActiveFlow External Breast Form Size 03
Trulife Limited
0063003
In Commercial Distribution

  • 00645517612638 ()


  • External breast prosthesis
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC41X
In Commercial Distribution

  • 10850025153499 ()
  • 00850025153492 ()
  • 50850025153497 ()
EMEC41X

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC36L
In Commercial Distribution

  • 10850025153482 ()
  • 00850025153485 ()
  • 50850025153480 ()
EMEC36L

  • Urinary incontinence penis sheath/port, single-use
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
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