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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Vest Skirt with Belt Large Male- Regular Lead (RL): Vest 0.5mm Front / 1.0mm Overlap / 0.3mm Back - Skirt 0.3mm Front / 0.6mm Overlap / 0.3mm Back
Shielding International Inc.
VSBLMRL
In Commercial Distribution

  • G031VSBLMRL0 ()


  • Radiation shielding apron
Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
MYOTRONICS NOROMED, INC
4060
In Commercial Distribution

  • D79240602 ()


  • Transcutaneous electrical stimulation electrode, single-use
Basket with lid for sterilization of adult endoscopes (External dimensions: 640 x 150 x 77 mm)
EFER ENDOSCOPY
DJ-4046-SPEC
In Commercial Distribution

  • G006DJ4046SPEC927 ()


  • Rigid optical bronchoscope
Basket for sterilization with lid and without silicone mat (External dimensions: 280 x 145 x 50 mm)
EFER ENDOSCOPY
DJ-4371
In Commercial Distribution

  • G006DJ4371178 ()


  • Rigid optical bronchoscope
Flex Arm with Clamp
KOROS U.S.A., INC.
7332-98
In Commercial Distribution

  • 00840199516308 ()
  • 10840199516305 ()

  • 9x12mm
7332-98

  • Surgical retraction system, reusable
CENTRAL SCREW TA6V Ø4.5mm L.20mm
FX SOLUTIONS
105-4520
In Commercial Distribution

  • 03701037313374 ()
105-4520

  • Orthopaedic bone screw (non-sliding)
CENTRAL SCREW TA6V Ø4.5mm L.18mm
FX SOLUTIONS
105-4518
In Commercial Distribution

  • 03701037313367 ()
105-4518

  • Orthopaedic bone screw (non-sliding)
CENTRAL SCREW TA6V Ø4.5mm L.16mm
FX SOLUTIONS
105-4516
In Commercial Distribution

  • 03701037313350 ()
105-4516

  • Orthopaedic bone screw (non-sliding)
CENTRAL SCREW TA6V Ø4.5mm L.14mm
FX SOLUTIONS
105-4514
In Commercial Distribution

  • 03701037313343 ()
105-4514

  • Orthopaedic bone screw (non-sliding)
CENTRAL SCREW TA6V Ø4.5mm L.12mm
FX SOLUTIONS
105-4512
In Commercial Distribution

  • 03701037313336 ()
105-4512

  • Shoulder prosthesis screw
CENTRAL SCREW TA6V Ø4.5mm L.10mm
FX SOLUTIONS
105-4510
In Commercial Distribution

  • 03701037313329 ()
105-4510

  • Orthopaedic bone screw (non-sliding)
CENTRAL SCREW TA6V Ø4.5mm L.08mm
FX SOLUTIONS
105-4508
In Commercial Distribution

  • 03701037313312 ()
105-4508

  • Orthopaedic bone screw (non-sliding)
HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm
FX SOLUTIONS
105-0028
In Commercial Distribution

  • 03701037313305 ()
105-0028

  • Shoulder glenoid fossa prosthesis, prefabricated
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
E
In Commercial Distribution

  • 10810190015657 ()
604200st

  • Suturing unit, reusable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014353 ()
397300a

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190013981 ()
397300bsm

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017064 ()
397300t

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
E
In Commercial Distribution

  • 10810190015312 ()
397300st

  • Clamp manipulation forceps
The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.
VORTRAN MEDICAL TECHNOLOGY 1, INC
IPW-4021
In Commercial Distribution

  • 20637320040214 ()
  • 10637320040217 ()
IPW-4021

  • Ultrasonic nebulizing system
No Description
Zimmer GmbH
75.00.03
In Commercial Distribution

  • 00889024302280 ()
75.00.03

  • Joint prosthesis implantation kit, reusable
No Description
Zimmer GmbH
6835
In Commercial Distribution

  • 00889024301559 ()
6835

  • Femoral stem prosthesis trial
Round bar with rider Female part E L50
Cendres+Métaux SA
05000679
In Commercial Distribution

  • 07640166515111 ()
05000679

  • Bar dental precision attachment
Round bar with rider Transfer jig
Cendres+Métaux SA
072293
In Commercial Distribution

  • 07640166514831 ()
072293

  • Dental precision attachment simulator/analog, single-use
Round bar with rider Female part E
Cendres+Métaux SA
055801
In Commercial Distribution

  • 07640239931602 ()
  • 07640166514213 ()
055801

  • Bar dental precision attachment
Round bar with rider Female part E
Cendres+Métaux SA
050527
In Commercial Distribution

  • 07640166513797 ()
050527

  • Bar dental precision attachment
BUTTON WITH HOOK BONDING MJANSON
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
30.10.2008
In Commercial Distribution

  • 07908611211200 ()


  • Orthodontic tube
Micro-Introducer Kit with Side-Holes
GALT MEDICAL CORP.
KIT-033-04
In Commercial Distribution

  • 20841268105748 ()
  • 10841268105741 ()
  • 00841268105744 ()

  • Catheter Gauge: 4 French
KIT-033-04

  • Vascular catheter introduction set, nonimplantable
Micro-Introducer Kit with Side-Holes
GALT MEDICAL CORP.
KIT-033-24
Not in Commercial Distribution

  • 20841268105755 ()
  • 10841268105758 ()
  • 00841268105751 ()

  • Catheter Gauge: 4 French
KIT-033-24

  • Vascular catheter introduction set, nonimplantable
Syvek Brace with Straps
Marine Polymer Technologies, Inc.
420-05
In Commercial Distribution

  • 10389142000039 ()
  • 00389142000032 ()


  • Wrist immobilizer, single-use
AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer
No Description
Paradigm Spine GmbH
RAT20500
In Commercial Distribution

  • 04260148897689 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
HAT50005
In Commercial Distribution

  • 04260148896613 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT50005
In Commercial Distribution

  • 04260148893322 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6195-1-001
In Commercial Distribution

  • 24260056885765 ()
  • 14260056885768 ()
  • 04260056885761 ()

  • Total Volume: 20 Milliliter
  • Weight: 40.8 Gram
6195-1-010

  • Orthopaedic cement, antimicrobial
Reusable Probes with holes.
APPLIED MEDICAL RESOURCES CORPORATION
C6204
Not in Commercial Distribution

  • 00607915117078 ()

  • Length: 33 Centimeter
  • Outer Diameter: 10 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0652
Not in Commercial Distribution

  • 10607915114951 ()
  • 00607915114954 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 12 Millimeter


  • Laparoscopic access cannula, single-use
Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0651
Not in Commercial Distribution

  • 10607915114944 ()
  • 00607915114947 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 11 Millimeter


  • Laparoscopic access cannula, single-use
BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 53600
In Commercial Distribution

  • 00607567209978 ()
709000218

  • Cardiopulmonary bypass system blood tubing set
Softshell venous reservoir 1900 BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 21308
Not in Commercial Distribution

  • 00607567207141 ()
701068376

  • Cardiopulmonary bypass system blood tubing set
BEQ HMOD 30000 Blood Transfer Bag Better Bladder Blood Microfilter System Cardiopegia Filter Gas Filter Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 24105
Not in Commercial Distribution

  • 00607567205574 ()
701064757

  • Cardiopulmonary bypass system blood tubing set
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