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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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Syvek Brace with Straps - 00389142000032

Syvek Brace with Straps
Marine Polymer Technologies, Inc.
420-05
In Commercial Distribution

  • 10389142000039 ()
  • 00389142000032 ()


  • Wrist immobilizer, single-use

PVC Drain with Trocar - 00801741050145

PVC Drain with Trocar, Large 1/4" (19 Fr., 6.3mm) O.D., 12.5" (31.7cm) Hole Pattern, X-Ray Opaque Stripe, with Attached Trocar
C. R. Bard, Inc.
0080730
In Commercial Distribution

  • 10801741050142 ()
  • 00801741050145 ()

  • Catheter Gauge: 19 French
0080730

  • Closed-wound drain, non-bioabsorbable

PVC Drain with Trocar - 00801741050138

PVC Drain with Trocar, Medium-Large 3/16" (15 Fr., 4.7mm) O.D., 12.5" (31.7cm) Hole Pattern, X-Ray Opaque Stripe, with Attached Trocar
C. R. Bard, Inc.
0080720
In Commercial Distribution

  • 10801741050135 ()
  • 00801741050138 ()

  • Catheter Gauge: 15 French
0080720

  • Closed-wound drainage kit

PVC Drain with Trocar - 00801741050121

PVC Drain with Trocar, Medium 1/8" (10 Fr., 3.2mm) O.D., 12.5" (31.7cm) Hole Pattern, X-Ray Opaque Stripe, with Attached Trocar
C. R. Bard, Inc.
0080710
In Commercial Distribution

  • 10801741050128 ()
  • 00801741050121 ()

  • Catheter Gauge: 10 French
0080710

  • Closed-wound drainage kit

PVC Drain with Trocar - 00801741050114

PVC Drain with Trocar, Small 3/32" (7 Fr., 2.3mm) O.D., 12.5" (31.7cm) Hole Pattern, X-Ray Opaque Stripe, with Attached Trocar
C. R. Bard, Inc.
0080700
In Commercial Distribution

  • 10801741050111 ()
  • 00801741050114 ()

  • Catheter Gauge: 7 French
0080700

  • Closed-wound drainage kit

ANCHOR ASSEMBLY WITH BOLT - 00887868001543

No Description
Biomet Orthopedics, LLC
10485
In Commercial Distribution

  • 00887868001543 ()
10485

  • External orthopaedic fixation system, single-use

NeuroNav with MER Headstage - 27290114063276

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with MER Headstage
In Commercial Distribution

  • 27290114063276 ()
NNW-025023-55

  • Depth electrode

NeuroNav with MER Headstage - 27290114060879

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with MER Headstage
In Commercial Distribution

  • 27290114060879 ()
NNW-025023-55

  • Depth electrode

NeuroSmart with NeuroFortis Drive - 27290114060435

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive
In Commercial Distribution

  • 27290114060435 ()
NSW-026010-55

  • Depth electrode

NeuroSmart with NeuroFortis Drive - 27290016450082

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive
In Commercial Distribution

  • 27290016450082 ()
NSW-026010-55

  • Depth electrode

NeuroNav with NeuroNav Drive - 27290016450051

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroNav Drive
In Commercial Distribution

  • 27290016450051 ()
NNW-026000-55

  • Depth electrode

NeuroNav with NeuroFortis Drive - 27290016450044

NeuroNav system with NeuroFortis Drive : NeurFortis Drive requires sterilization before use.
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroFortis Drive
In Commercial Distribution

  • 27290016450044 ()
NNW-006010-55

  • Depth electrode

AEROBIKA OPEP with Manometer - 00762860105041

AEROBIKA OPEP with Manometer
Trudell Medical International
110504
In Commercial Distribution

  • 10762860105048 ()
  • 00762860105041 ()
  • 62860110504023 ()


  • Positive pressure airway secretion-clearing device

RESPICHAMBER* VHC with Mouthpiece - 00762860001138

RESPICHAMBER™ VHC with Mouthpiece
Trudell Medical International
101533
In Commercial Distribution

  • 10762860001135 ()
  • 00762860001138 ()


  • Medicine chamber spacer, reusable

Vessel Dilator with Collar - 00886333210558

Vessel Dilator with Collar 9 French
ARGON MEDICAL DEVICES, INC.
392414
Not in Commercial Distribution

  • 10886333210555 ()
  • 00886333210558 ()

  • 9 French
392414

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210534

Vessel Dilator with Collar 7 French
ARGON MEDICAL DEVICES, INC.
392412
Not in Commercial Distribution

  • 10886333210531 ()
  • 00886333210534 ()

  • 7 French
392412

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210541

Vessel Dilator with Collar 8F
ARGON MEDICAL DEVICES, INC.
392413
Not in Commercial Distribution

  • 10886333210548 ()
  • 00886333210541 ()

  • 8 French
392413

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210527

Vessel Dilator with Collar 6 French
ARGON MEDICAL DEVICES, INC.
392411
Not in Commercial Distribution

  • 10886333210524 ()
  • 00886333210527 ()

  • 6 French
392411

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210510

Vessel Dilator with Collar 5 French
ARGON MEDICAL DEVICES, INC.
392410
Not in Commercial Distribution

  • 10886333210517 ()
  • 00886333210510 ()

  • 5 French
392410

  • Fascial tissue dilator, single-use

Restylane Lyft with Lidocaine - 07331689117141

No Description
Q-Med AB
Gel 1 mL Syringe
In Commercial Distribution

  • 07331689117141 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane Lyft with Lidocaine - 07331689117066

No Description
Q-Med AB
Gel 1.0 ml syringe - Demo
In Commercial Distribution

  • 07331689117066 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane Lyft with Lidocaine - 07331689114027

No Description
Q-Med AB
Gel 1 mL - Demo
In Commercial Distribution

  • 07331689114027 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane Lyft with Lidocaine - 07331689114010

No Description
Q-Med AB
Gel 1 mL Syringe
In Commercial Distribution

  • 07331689114010 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

T-Handle with Pendulum Adaptor - 07290115934298

No Description
PREMIA SPINE LTD
86263
In Commercial Distribution

  • 07290115934298 ()


  • Surgical instrument handle, non-torque-limiting

K-Wire with stop 1.6mm - M209209420

No Description
BIOPRO, INC.
20942
In Commercial Distribution

  • M209209420 ()


  • Orthopaedic bone wire

K-Wire with stop 1.4mm - M209209410

No Description
BIOPRO, INC.
20941
In Commercial Distribution

  • M209209410 ()


  • Orthopaedic bone wire

K-Wire with stop 1.2mm - M209209400

No Description
BIOPRO, INC.
20940
In Commercial Distribution

  • M209209400 ()


  • Orthopaedic bone wire

K-Wire with stop 1.0mm - M209206660

No Description
BIOPRO, INC.
20666
In Commercial Distribution

  • M209206660 ()


  • Orthopaedic bone wire

Affinity Home with accessories - 07290017249063

Affinity G.J.S with accessories MP
TAVGER LTD
FG00016
In Commercial Distribution

  • 07290017249063 ()


  • Surgical/orthopaedic lavage control unit

Affinity G.J.S with accessories - 07290017249056

Affinity G.J.S with accessories ASS
TAVGER LTD
FG00014
In Commercial Distribution

  • 07290017249056 ()


  • Surgical/orthopaedic lavage control unit

TR1000 with straight armrests - 07350016060004

TR1000 with straight armrests
Tr Equipment AB
0521000
In Commercial Distribution

  • 07350016060004 ()


  • Bathing/changing table, mobile

Back-N-Black with Dual Panels - 00802357632572

No Description
MEDICAL SPECIALTIES INCORPORATED
163257
In Commercial Distribution

  • 00802357632572 ()


  • Lumbar spine orthosis

Back-N-Black with Dual Panels - 00802357632565

No Description
MEDICAL SPECIALTIES INCORPORATED
163256
In Commercial Distribution

  • 00802357632565 ()


  • Lumbar spine orthosis

Back-N-Black with Dual Panels - 00802357632558

No Description
MEDICAL SPECIALTIES INCORPORATED
163255
In Commercial Distribution

  • 00802357632558 ()


  • Lumbar spine orthosis

Back-N-Black with Dual Panels - 00802357632541

No Description
MEDICAL SPECIALTIES INCORPORATED
163254
In Commercial Distribution

  • 00802357632541 ()


  • Lumbar spine orthosis

Back-N-Black with Dual Panels - 00802357632527

No Description
MEDICAL SPECIALTIES INCORPORATED
163252
In Commercial Distribution

  • 00802357632527 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632275

No Description
MEDICAL SPECIALTIES INCORPORATED
163227
In Commercial Distribution

  • 00802357632275 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632268

No Description
MEDICAL SPECIALTIES INCORPORATED
163226
In Commercial Distribution

  • 00802357632268 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632251

No Description
MEDICAL SPECIALTIES INCORPORATED
163225
In Commercial Distribution

  • 00802357632251 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632244

No Description
MEDICAL SPECIALTIES INCORPORATED
163224
In Commercial Distribution

  • 00802357632244 ()


  • Lumbar spine orthosis
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