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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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BioHorizons - 00847236002169

External 4.0/5.0/6.0mm Ball-top Screw
BIOHORIZONS IMPLANT SYSTEMS, INC
214-235
In Commercial Distribution

  • 00847236002169 ()


  • Dental prosthesis/implant abutment screw analog, reusable

BioHorizons - 00847236001902

External 4.0/5.0/6.0mm Abutment Screw
BIOHORIZONS IMPLANT SYSTEMS, INC
140-300
In Commercial Distribution

  • 00847236001902 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236000288

External 5.0mm Ball Abutment, 6mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
265-006
Not in Commercial Distribution

  • 00847236000288 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236000271

External 4.0mm Ball Abutment, 6mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
264-006
Not in Commercial Distribution

  • 00847236000271 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236000264

External 3.5mm Ball Abutment, 6mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
263-006
Not in Commercial Distribution

  • 00847236000264 ()


  • Dental implant suprastructure, permanent, preformed

U2™ Knee - 04719872174615

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

U2™ Knee - 04719872174608

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

U2™ Knee - 04719872174592

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

Distender II Barostat - 00627843670896

External Reservoir Unit 1300/120 mL
G&J Electronics Inc
ERU-1300-120
In Commercial Distribution

  • 00627843670896 ()


  • Gastrointestinal barostat

Thumper - 00860682000114

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

  • 00860682000114 ()
15370

  • Cardiac resuscitator, pneumatic

Life-Stat - 00860682000121

External Cardiac Compressor - Life-Stat Model 1008MII
MICHIGAN INSTRUMENTS, LLC
1008MII
In Commercial Distribution

  • 00860682000121 ()
16000

  • Cardiac resuscitator, pneumatic

remede EL/EL-X External Pulse Generator - 00857688007414

remede EL/EL-X external pulse generator
RESPICARDIA, INC.
1006A
In Commercial Distribution

  • 00857688007414 ()


  • Transvenous phrenic nerve electrical stimulation control unit

Luke Replaceable Part - 00859503006497

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

  • 00859503006497 ()


  • Myoelectric hand prosthesis

Luke Replaceable Part - 00859503006480

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

  • 00859503006480 ()


  • Myoelectric hand prosthesis

Trulife - 00645517723693

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

  • 00645517723693 ()


  • External breast prosthesis

Trulife - 00645517612812

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

  • 00645517612812 ()


  • External breast prosthesis

Trulife - 00645517612775

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

  • 00645517612775 ()


  • External breast prosthesis

Trulife - 00645517612737

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

  • 00645517612737 ()


  • External breast prosthesis

TruCath - 00850025153492

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 - 00850025153485

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 - 00850025153478

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 - 00850025153461

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 - 00850025153454

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 - 00850025153447

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 - 00850025153430

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 - 00850025153423

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 - 00850025153416

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 - 00850025153409

TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
SMEC25S
In Commercial Distribution

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

  • Urinary incontinence penis sheath/port, single-use

NA - 05415067051882

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

Trulife - 00645517723716

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

  • 00645517723716 ()


  • External breast prosthesis

Trulife - 00645517612874

ActiveFlow External Breast Form Size 14
Trulife Limited
0063014
In Commercial Distribution

  • 00645517612874 ()


  • External breast prosthesis

Trulife - 00645517612850

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

  • 00645517612850 ()


  • External breast prosthesis

Trulife - 00645517612836

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

  • 00645517612836 ()


  • External breast prosthesis

Trulife - 00645517612799

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

  • 00645517612799 ()


  • External breast prosthesis

Trulife - 00645517612751

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

  • 00645517612751 ()


  • External breast prosthesis

Trulife - 00645517612713

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

  • 00645517612713 ()


  • External breast prosthesis

Trulife - 00645517612690

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

  • 00645517612690 ()


  • External breast prosthesis

Trulife - 00645517612676

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

  • 00645517612676 ()


  • External breast prosthesis

Trulife - 00645517612638

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

  • 00645517612638 ()


  • External breast prosthesis

Solo Pace Control System - 00850056280037

Solo Pace Control External Pulse Generator
SOLO PACE INC.
SOLOEPG1L
In Commercial Distribution

  • 00850056280037 ()


  • External pacemaker, epicardial pacing

7 EXTERNAL EYELID WEIGHTS SIZING SET - 13700773727947

7 EXTERNAL EYELID WEIGHTS SIZING SET
FCI S A S FCI 20 22
S3.7000
In Commercial Distribution

  • 13700773727947 ()


  • Eyelid weight, external

EXTERNAL OCULID TAN® - 1,8 g - 13700773727916

EXTERNAL OCULID TAN® - 1,8 g
FCI S A S FCI 20 22
S3.60182
In Commercial Distribution

  • 13700773727916 ()


  • Eyelid weight, external

EXTERNAL OCULID PINK® - 1,8 g - 13700773727909

EXTERNAL OCULID PINK® - 1,8 g
FCI S A S FCI 20 22
S3.60181
In Commercial Distribution

  • 13700773727909 ()


  • Eyelid weight, external

EXTERNAL OCULID LIGHT® - 1,8 g - 13700773727893

EXTERNAL OCULID LIGHT® - 1,8 g
FCI S A S FCI 20 22
S3.60180
In Commercial Distribution

  • 13700773727893 ()


  • Eyelid weight, external

EXTERNAL OCULID TAN® - 1,6 g - 13700773727862

EXTERNAL OCULID TAN® - 1,6 g
FCI S A S FCI 20 22
S3.60162
In Commercial Distribution

  • 13700773727862 ()


  • Eyelid weight, external

EXTERNAL OCULID PINK® - 1,6 g - 13700773727855

EXTERNAL OCULID PINK® - 1,6 g
FCI S A S FCI 20 22
S3.60161
In Commercial Distribution

  • 13700773727855 ()


  • Eyelid weight, external

EXTERNAL OCULID LIGHT® - 1,6 - 13700773727848

EXTERNAL OCULID LIGHT® - 1,6 g
FCI S A S FCI 20 22
S3.60160
In Commercial Distribution

  • 13700773727848 ()


  • Eyelid weight, external

EXTERNAL OCULID TAN® - 1,4 g - 13700773727817

EXTERNAL OCULID TAN® - 1,4 g
FCI S A S FCI 20 22
S3.60142
In Commercial Distribution

  • 13700773727817 ()


  • Eyelid weight, external

EXTERNAL OCULID PINK® - 1,4 g - 13700773727800

EXTERNAL OCULID PINK® - 1,4 g
FCI S A S FCI 20 22
S3.60141
In Commercial Distribution

  • 13700773727800 ()


  • Eyelid weight, external

EXTERNAL OCULID LIGHT® - 1,4 g - 13700773727794

EXTERNAL OCULID LIGHT® - 1,4 g
FCI S A S FCI 20 22
S3.60140
In Commercial Distribution

  • 13700773727794 ()


  • Eyelid weight, external
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